Clinical Trials List
Protocol NumberGLPG1690-CL-303
NCT Number(ClinicalTrials.gov Identfier)NCT03711162
2019-04-01 - 2022-05-31
Phase III
Recruiting4
ICD-10J84.10
Pulmonary fibrosis, unspecified
A Phase 3, randomized, double-blind, parallel-group, placebo controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.
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Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
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Sponsor
Galapagos NV
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Te Liu Division of Thoracic Medicine
- Po-Hao Feng Division of Thoracic Medicine
- Ching-Shan Luo Division of Thoracic Medicine
- Kuan-Yuan Chen Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
- Tzu-Tao Chen Division of Thoracic Medicine
- Chien-Hua Tseng Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
1 Recruiting
Audit
CRO
Co-Principal Investigator
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Ming-Ju Tsai Division of Thoracic Medicine
- 鄭至宏 Division of Thoracic Medicine
- Jen-Yu Hung Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- 鄭孟軒 Division of Thoracic Medicine
- 陳家閔 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
idiopathic pulmonary fibrosis
Objectives
main purpose
For subjects with idiopathic pulmonary fibrosis (IPF) receiving local standard care, the efficacy of two doses of GLPG1690 compared to placebo was evaluated by the 52-week decline rate of forced vital capacity (FVC)
Secondary purpose
Important secondary purpose
Compared with placebo, IPF subjects were evaluated for the effects of receiving two additional doses of GLPG1690 under local standard care on the following items:
*Illness worsening, which is defined as FVC worsening or all-cause mortality at 52 weeks
*Respiratory-related hospitalization until the end of the trial
*Change in quality of life at 52 weeks (measured based on the total score of the Respiratory Symptom Questionnaire [SGRQ] at St. George's Hospital)
Test Drug
GLPG1690 (G451990)
Active Ingredient
GLPG1690 (G451990)
Dosage Form
tablet
Dosage
200 mg or 100mg/tab
Endpoints
[main indicators]
FVC fall rate during 52 weeks (in mL)
[Secondary indicator]
Key secondary indicators
-Disease deterioration, which is defined as the first occurrence of predicted forced vital capacity (%FVC) at 52 weeks ≥10% absolute decrease percentage or a comprehensive indicator of all-cause mortality
-By the end of the trial, the time to the first respiratory-related hospitalization
-The change in the total SGRQ score compared to the base period at 52 weeks
Other secondary indicators
-FVC drop rate by the end of the experiment (in mL)
-Disease deterioration, which is defined as the first occurrence of %FVC ≥10% absolute decline or all-cause mortality by the end of the trial
-By the end of the trial, the change in the total SGRQ score compared to the base period
-Time to the first all-cause non-selective hospitalization by the end of the trial
-Time to respiratory-related deaths by the end of the trial
-By the end of the trial, when lung transplantation occurred
-By the end of the trial, the time to the first exacerbation of acute IPF
-By the end of the trial, the time for all-cause death or lung transplantation
-By the end of the trial, when all-cause death or lung transplantation occurs, or when eligible for lung transplantation
-By the end of the trial, all-cause death, %FVC ≥10% absolute decrease, or respiratory-related hospital stay occurred
-By the end of the trial, the time for all-cause deaths or respiratory-related hospitalizations
-FVC analysis at 52 weeks and at the end of the trial:
*The absolute and relative changes of FVC and %FVC from the base period
*By the end of the experiment, the absolute category change of %FVC: decrease >5, increase >5, and change within
-Changes in cough-related quality of life (assessed by the total LCQ score and the range of changes over time, and VAS coughing and wanting to cough) compared to the baseline at 52 weeks and at the end of the trial
-The change in quality of life compared to the baseline at 52 weeks and at the end of the trial (evaluated by the total EQ-5D and K-BILD scores and the range of changes over time)
-At 52 weeks and at the end of the trial, assess the plasma concentrations of GLPG1690, pirfenidone and nintedanib (if applicable)
-Changes in functional motor performance compared to the baseline at 52 weeks and at the end of the trial (evaluated by a 6-minute walk test (6MWT) distance)
-Changes in the diffusivity of carbon monoxide (DLCO) compared to the base period at 52 weeks and at the end of the test (corrected by heme [Hb])
[Other indicators]
-By the end of the experiment, the change of target biomarker/PD in blood over time compared to the base period
-By the end of the trial, the change in blood disease-specific biomarkers over time compared to the baseline period
-Efficacy and biomarker indicators of sub-groups by genotype
-At 52 weeks and at the end of the trial, the Borg scale changes from the baseline before and after 6MWT
-By the end of the experiment, the change in SpO2 compared to the base period
-Health resource utilization parameters by the end of the trial
FVC fall rate during 52 weeks (in mL)
[Secondary indicator]
Key secondary indicators
-Disease deterioration, which is defined as the first occurrence of predicted forced vital capacity (%FVC) at 52 weeks ≥10% absolute decrease percentage or a comprehensive indicator of all-cause mortality
-By the end of the trial, the time to the first respiratory-related hospitalization
-The change in the total SGRQ score compared to the base period at 52 weeks
Other secondary indicators
-FVC drop rate by the end of the experiment (in mL)
-Disease deterioration, which is defined as the first occurrence of %FVC ≥10% absolute decline or all-cause mortality by the end of the trial
-By the end of the trial, the change in the total SGRQ score compared to the base period
-Time to the first all-cause non-selective hospitalization by the end of the trial
-Time to respiratory-related deaths by the end of the trial
-By the end of the trial, when lung transplantation occurred
-By the end of the trial, the time to the first exacerbation of acute IPF
-By the end of the trial, the time for all-cause death or lung transplantation
-By the end of the trial, when all-cause death or lung transplantation occurs, or when eligible for lung transplantation
-By the end of the trial, all-cause death, %FVC ≥10% absolute decrease, or respiratory-related hospital stay occurred
-By the end of the trial, the time for all-cause deaths or respiratory-related hospitalizations
-FVC analysis at 52 weeks and at the end of the trial:
*The absolute and relative changes of FVC and %FVC from the base period
*By the end of the experiment, the absolute category change of %FVC: decrease >5, increase >5, and change within
-Changes in cough-related quality of life (assessed by the total LCQ score and the range of changes over time, and VAS coughing and wanting to cough) compared to the baseline at 52 weeks and at the end of the trial
-The change in quality of life compared to the baseline at 52 weeks and at the end of the trial (evaluated by the total EQ-5D and K-BILD scores and the range of changes over time)
-At 52 weeks and at the end of the trial, assess the plasma concentrations of GLPG1690, pirfenidone and nintedanib (if applicable)
-Changes in functional motor performance compared to the baseline at 52 weeks and at the end of the trial (evaluated by a 6-minute walk test (6MWT) distance)
-Changes in the diffusivity of carbon monoxide (DLCO) compared to the base period at 52 weeks and at the end of the test (corrected by heme [Hb])
[Other indicators]
-By the end of the experiment, the change of target biomarker/PD in blood over time compared to the base period
-By the end of the trial, the change in blood disease-specific biomarkers over time compared to the baseline period
-Efficacy and biomarker indicators of sub-groups by genotype
-At 52 weeks and at the end of the trial, the Borg scale changes from the baseline before and after 6MWT
-By the end of the experiment, the change in SpO2 compared to the base period
-Health resource utilization parameters by the end of the trial
Inclution Criteria
Inclusion conditions
Subjects who meet all of the following conditions are eligible to participate in this clinical trial:
1. Before conducting any screening assessment, be able and willing to comply with the requirements of the trial plan and sign the subject consent form (ICF) approved by the Independent Ethics Committee (IEC)/Human Testing Committee (IRB).
2. The subject must be able and willing to comply with the restrictions on previous and concomitant medications.
3. Sign the subject's consent form. On the day, male or female subjects aged ≥40 years old.
4. According to the revised standard.
4.1 At the time of diagnosis, according to the applicable American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Society (ALAT) guidelines, diagnosed as idiopathic lung within 5 years before the screening return Fibrosis.
5. High-resolution computerized tomography (HRCT) of the chest was performed in the 12 months before the screening visit, and the central laboratory used the HRCT of the subject only according to the minimum requirements of IPF diagnosis (if there is no available lungs). Tissue section (LB)) or at the same time HRCT and LB for review (different standards apply according to individual circumstances). If you have not obtained an evaluable HRCT <12 months before screening, you can perform HRCT during screening to determine eligibility based on the same requirements as the past HRCT.
6. According to the revised standard.
6.1 Local standard care for receiving IPF treatment (defined as receiving a stable dose of pirfenidone (bilesuhuo tablet) or nintedanib (pulmonary fibrosis) for at least two months before and during screening, or receiving neither pirfenidone nor Subjects who received nintedanib [for any reason]). The stable dose is defined as the highest dose tolerated by the subject during these two months.
7. In the most recent HRCT scan, the degree of fibrosis change was greater than the degree of emphysema (determined by the trial host).
8. All of the following conditions are met during the screening:
-Forced Vital Capacity (FVC) ≥45% predicted normal value.
-Forced expiratory volume (FEV1)/forced vital capacity (FVC) in 1 second≥0.7.
-Hb corrected carbon monoxide diffusion capacity (DLCO) ≥30% predicted normal value.
9. Based on revised standards.
9.1 According to the medical history, physical examination, vital signs, 12-lead ECG and laboratory evaluation results, they are in a stable state and suitable to participate in the trial. The stable state is based on the clinical judgment of the trial host; the comorbidities should be treated according to local applicable guidelines. Concomitant drugs for chronic comorbidities should be used stably 4 weeks before screening and during the screening period (stable is defined as no clinically relevant changes based on the judgment of the trial abbot).
10. According to the opinion of the trial host, the shortest average life expectancy for non-IPF-related diseases is estimated to be at least 30 months.
11. Male subjects and female subjects with fertility agree from taking the first dose of IMP (male subjects) or signing ICF (female subjects), during the trial and 90 days after taking the last dose of IMP (Male) or 30 days (female), use high-efficiency contraception/violent drug prevention measures (details are provided in the complete trial plan).
12. Based on revised standards.
12.1 Able to walk at least 150 meters during the 6-minute walk test (6MWT) during the first return visit of the screening; not prohibited from performing the 6MWT or not equipped to put the subject at risk of falling during the test (by the test host) determination). Canes can be used, but carts are not allowed under any circumstances. At the second visit, for the oxygen content measurement, the resting blood oxygen saturation (SpO2) should be ≥88%, and the maximum value should be 6 L O2/min; during walking, SpO2 should be ≥ 83%, 6 L O2/min or ≥88%, 0, 2 or 4 L O2/min.
13. Be able to read and fill in the Taiwanese Traditional Chinese Version of the Health Questionnaire (EQ-5D), St. George's Hospital Respiratory Symptom Questionnaire (SGRQ), Leicester Cough Questionnaire (LCQ), K-BILD Questionnaire (K-BILD) and VAS Scale.
14. Able to understand the importance of compliance, and be willing to comply with experimental treatment, experimental procedures and requirements, including restrictions on concomitant drugs, in accordance with the experimental plan.
Subjects who meet all of the following conditions are eligible to participate in this clinical trial:
1. Before conducting any screening assessment, be able and willing to comply with the requirements of the trial plan and sign the subject consent form (ICF) approved by the Independent Ethics Committee (IEC)/Human Testing Committee (IRB).
2. The subject must be able and willing to comply with the restrictions on previous and concomitant medications.
3. Sign the subject's consent form. On the day, male or female subjects aged ≥40 years old.
4. According to the revised standard.
4.1 At the time of diagnosis, according to the applicable American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Society (ALAT) guidelines, diagnosed as idiopathic lung within 5 years before the screening return Fibrosis.
5. High-resolution computerized tomography (HRCT) of the chest was performed in the 12 months before the screening visit, and the central laboratory used the HRCT of the subject only according to the minimum requirements of IPF diagnosis (if there is no available lungs). Tissue section (LB)) or at the same time HRCT and LB for review (different standards apply according to individual circumstances). If you have not obtained an evaluable HRCT <12 months before screening, you can perform HRCT during screening to determine eligibility based on the same requirements as the past HRCT.
6. According to the revised standard.
6.1 Local standard care for receiving IPF treatment (defined as receiving a stable dose of pirfenidone (bilesuhuo tablet) or nintedanib (pulmonary fibrosis) for at least two months before and during screening, or receiving neither pirfenidone nor Subjects who received nintedanib [for any reason]). The stable dose is defined as the highest dose tolerated by the subject during these two months.
7. In the most recent HRCT scan, the degree of fibrosis change was greater than the degree of emphysema (determined by the trial host).
8. All of the following conditions are met during the screening:
-Forced Vital Capacity (FVC) ≥45% predicted normal value.
-Forced expiratory volume (FEV1)/forced vital capacity (FVC) in 1 second≥0.7.
-Hb corrected carbon monoxide diffusion capacity (DLCO) ≥30% predicted normal value.
9. Based on revised standards.
9.1 According to the medical history, physical examination, vital signs, 12-lead ECG and laboratory evaluation results, they are in a stable state and suitable to participate in the trial. The stable state is based on the clinical judgment of the trial host; the comorbidities should be treated according to local applicable guidelines. Concomitant drugs for chronic comorbidities should be used stably 4 weeks before screening and during the screening period (stable is defined as no clinically relevant changes based on the judgment of the trial abbot).
10. According to the opinion of the trial host, the shortest average life expectancy for non-IPF-related diseases is estimated to be at least 30 months.
11. Male subjects and female subjects with fertility agree from taking the first dose of IMP (male subjects) or signing ICF (female subjects), during the trial and 90 days after taking the last dose of IMP (Male) or 30 days (female), use high-efficiency contraception/violent drug prevention measures (details are provided in the complete trial plan).
12. Based on revised standards.
12.1 Able to walk at least 150 meters during the 6-minute walk test (6MWT) during the first return visit of the screening; not prohibited from performing the 6MWT or not equipped to put the subject at risk of falling during the test (by the test host) determination). Canes can be used, but carts are not allowed under any circumstances. At the second visit, for the oxygen content measurement, the resting blood oxygen saturation (SpO2) should be ≥88%, and the maximum value should be 6 L O2/min; during walking, SpO2 should be ≥ 83%, 6 L O2/min or ≥88%, 0, 2 or 4 L O2/min.
13. Be able to read and fill in the Taiwanese Traditional Chinese Version of the Health Questionnaire (EQ-5D), St. George's Hospital Respiratory Symptom Questionnaire (SGRQ), Leicester Cough Questionnaire (LCQ), K-BILD Questionnaire (K-BILD) and VAS Scale.
14. Able to understand the importance of compliance, and be willing to comply with experimental treatment, experimental procedures and requirements, including restrictions on concomitant drugs, in accordance with the experimental plan.
Exclusion Criteria
Exclude conditions
Subjects who meet one or more of the following conditions cannot be selected for this clinical trial:
1. The test host or other test personnel or their relatives directly involved in the execution of the test.
2. Any clinical conditions or other conditions or circumstances that may make the subject unsuitable for inclusion in the trial or unlikely or unable to complete the trial or comply with the trial procedures and requirements by the trial host.
3. Participated in the clinical trial of GLPG1690 (active or placebo) before.
4. Known allergies to any IMP component or have a significant allergic reaction to any drug (such as systemic allergic reaction requiring hospitalization) as determined by the test host.
5. According to the revised standard.
5.1 An immunosuppressive disorder (such as human immunodeficiency virus [HIV] infection, congenital, acquired, drug-induced).
6. According to the revised standard.
6.1 A positive blood test result for hepatitis B surface antigen (HBs Ag) or hepatitis C virus (antibody, confirmed by positive hepatitis C virus [HCV] RNA). Note: Subjects whose hepatitis A has been relieved for at least 3 months before screening can be screened.
7. Suffered from malignant tumors in the past 5 years (carcinoma in situ of the cervix, basal cell carcinoma of the skin that has received treatment without evidence of recurrence, prostate cancer that has undergone medical treatment through active surveillance or watchful waiting, and completely resected Except for skin squamous cell carcinoma and breast duct carcinoma in situ).
8. According to the revised standard.
8.1 A clinically significant heart rhythm or conduction abnormality is detected on the ECG, that is, QTcF> 450 ms, or known to have QT prolonged syndrome. Patients who are loaded with implantable cardiovascular equipment (such as pacemakers) that affect the QT interval can consult a cardiologist (if deemed necessary) and only after discussing with a medical monitor. The facilitator’s judgment was included in the trial.
9. The drugs currently taken are known to be metabolized by Cytochrome P450 (CYP) 2C8.
10. The drug currently being taken is known as a potent inducer of CYP3A4 and also contains Hypericum.
11. The drugs currently taken are known to be potent inhibitors of CYP3A4.
12. The drug currently being taken is known as a potent inducer of P-glycoprotein (P-gp).
13. The drugs currently taken are known to be potent inhibitors of P-gp.
14. Based on revised standards.
14.1 Acute exacerbation of IPF occurred within 6 months before screening and/or during screening. The definition of acute IPF exacerbation is as follows: previous or simultaneous diagnosis of IPF; acute exacerbation or dyspnea usually lasts <1 month; background pattern with new bilateral ground-glass plaques and/or superimposed computers Tomography is consistent with the common pattern of interstitial pneumonia, and the deterioration cannot be fully explained by heart failure or excess fluid volume.
15. A lower respiratory tract infection requiring antibiotic treatment occurred within 4 weeks before screening and/or during screening.
16. Suffering from interstitial lung disease related to known primary diseases (such as sarcoidosis and amyloidosis), exposure (such as radiation, silica, asbestos, and coal dust), or drugs (such as amiodarone).
17. Have received lung volume reduction surgery or lung transplantation. Note: Permission is currently on the waiting list for transplantation.
18. Diagnosis of severe pulmonary hypertension (determined by the test host).
19. Suffered from unstable cardiovascular, pulmonary (non-IPF) or other diseases (such as acute coronary artery disease, heart failure, and stroke) within 6 months prior to screening or during screening.
20. According to the revised standard.
20.1 Gastric perforation occurred within 3 months before screening or during screening, and/or had undergone major surgery within 3 months before screening or during screening or planned to undergo major surgery during the trial period.
21. According to the revised standard.
21.1 Any subject who has been sent to an institution by administrative or court order, if applicable in accordance with local laws, and is prohibited or restricted from participating in trials by applicable laws and regulations, is any subject of any type of person as a protected person.
22. According to the revised standard.
22.1 History of Nintedanib-related ALT and/or AST increase> 5xULN and increased sensitivity to elevated LFT; moderate to severe liver damage (Child-Pugh B or C) and/or abnormal liver function test (LFT) during screening , Defined as transamidation of aspartate enzyme(AST) and/or transamidation of alanine enzyme (ALT), and/or total bilirubin≥1.5xULN, and/or γ- Glutamine conversion enzyme(GGT) ≥3xULN. Abnormal LFT can be checked again.
23. Abnormal renal function, defined as the estimated value of creatinine clearance calculated by Cockcroft-Gault (CCr) <30 mL/min. Can be tested again.
24.Hb concentration <10 g/dL. Can be tested again.
25. According to the revised standard.
25.1 At the same time participating in another interventional drug, device or biological experimental research trial, or within 5 half-life of the drug before screening (or within 8 weeks when the half-life is unknown, or if the experimental drug is an antibody) Within 6 months) the use of experimental drugs is not permitted.
26. Plan to use any of the following therapies during the 4 weeks before and during the screening, or during the trial: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bossentan, methotrexate, sildenafil (except occasional use), prednisone stable Dose>10 mg/day or equivalent dose.
27. According to the trial host’s judgment, there is currently alcohol or drug abuse.
28. Be pregnant, breastfeeding, or plan to become pregnant or breastfeeding during the trial treatment period or within 30 days after the last dose of IMP.
29. Clinical laboratory tests suspected cholestasis and serum total bile acid concentration> 3xULN.
Subjects who meet one or more of the following conditions cannot be selected for this clinical trial:
1. The test host or other test personnel or their relatives directly involved in the execution of the test.
2. Any clinical conditions or other conditions or circumstances that may make the subject unsuitable for inclusion in the trial or unlikely or unable to complete the trial or comply with the trial procedures and requirements by the trial host.
3. Participated in the clinical trial of GLPG1690 (active or placebo) before.
4. Known allergies to any IMP component or have a significant allergic reaction to any drug (such as systemic allergic reaction requiring hospitalization) as determined by the test host.
5. According to the revised standard.
5.1 An immunosuppressive disorder (such as human immunodeficiency virus [HIV] infection, congenital, acquired, drug-induced).
6. According to the revised standard.
6.1 A positive blood test result for hepatitis B surface antigen (HBs Ag) or hepatitis C virus (antibody, confirmed by positive hepatitis C virus [HCV] RNA). Note: Subjects whose hepatitis A has been relieved for at least 3 months before screening can be screened.
7. Suffered from malignant tumors in the past 5 years (carcinoma in situ of the cervix, basal cell carcinoma of the skin that has received treatment without evidence of recurrence, prostate cancer that has undergone medical treatment through active surveillance or watchful waiting, and completely resected Except for skin squamous cell carcinoma and breast duct carcinoma in situ).
8. According to the revised standard.
8.1 A clinically significant heart rhythm or conduction abnormality is detected on the ECG, that is, QTcF> 450 ms, or known to have QT prolonged syndrome. Patients who are loaded with implantable cardiovascular equipment (such as pacemakers) that affect the QT interval can consult a cardiologist (if deemed necessary) and only after discussing with a medical monitor. The facilitator’s judgment was included in the trial.
9. The drugs currently taken are known to be metabolized by Cytochrome P450 (CYP) 2C8.
10. The drug currently being taken is known as a potent inducer of CYP3A4 and also contains Hypericum.
11. The drugs currently taken are known to be potent inhibitors of CYP3A4.
12. The drug currently being taken is known as a potent inducer of P-glycoprotein (P-gp).
13. The drugs currently taken are known to be potent inhibitors of P-gp.
14. Based on revised standards.
14.1 Acute exacerbation of IPF occurred within 6 months before screening and/or during screening. The definition of acute IPF exacerbation is as follows: previous or simultaneous diagnosis of IPF; acute exacerbation or dyspnea usually lasts <1 month; background pattern with new bilateral ground-glass plaques and/or superimposed computers Tomography is consistent with the common pattern of interstitial pneumonia, and the deterioration cannot be fully explained by heart failure or excess fluid volume.
15. A lower respiratory tract infection requiring antibiotic treatment occurred within 4 weeks before screening and/or during screening.
16. Suffering from interstitial lung disease related to known primary diseases (such as sarcoidosis and amyloidosis), exposure (such as radiation, silica, asbestos, and coal dust), or drugs (such as amiodarone).
17. Have received lung volume reduction surgery or lung transplantation. Note: Permission is currently on the waiting list for transplantation.
18. Diagnosis of severe pulmonary hypertension (determined by the test host).
19. Suffered from unstable cardiovascular, pulmonary (non-IPF) or other diseases (such as acute coronary artery disease, heart failure, and stroke) within 6 months prior to screening or during screening.
20. According to the revised standard.
20.1 Gastric perforation occurred within 3 months before screening or during screening, and/or had undergone major surgery within 3 months before screening or during screening or planned to undergo major surgery during the trial period.
21. According to the revised standard.
21.1 Any subject who has been sent to an institution by administrative or court order, if applicable in accordance with local laws, and is prohibited or restricted from participating in trials by applicable laws and regulations, is any subject of any type of person as a protected person.
22. According to the revised standard.
22.1 History of Nintedanib-related ALT and/or AST increase> 5xULN and increased sensitivity to elevated LFT; moderate to severe liver damage (Child-Pugh B or C) and/or abnormal liver function test (LFT) during screening , Defined as transamidation of aspartate enzyme(AST) and/or transamidation of alanine enzyme (ALT), and/or total bilirubin≥1.5xULN, and/or γ- Glutamine conversion enzyme(GGT) ≥3xULN. Abnormal LFT can be checked again.
23. Abnormal renal function, defined as the estimated value of creatinine clearance calculated by Cockcroft-Gault (CCr) <30 mL/min. Can be tested again.
24.Hb concentration <10 g/dL. Can be tested again.
25. According to the revised standard.
25.1 At the same time participating in another interventional drug, device or biological experimental research trial, or within 5 half-life of the drug before screening (or within 8 weeks when the half-life is unknown, or if the experimental drug is an antibody) Within 6 months) the use of experimental drugs is not permitted.
26. Plan to use any of the following therapies during the 4 weeks before and during the screening, or during the trial: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bossentan, methotrexate, sildenafil (except occasional use), prednisone stable Dose>10 mg/day or equivalent dose.
27. According to the trial host’s judgment, there is currently alcohol or drug abuse.
28. Be pregnant, breastfeeding, or plan to become pregnant or breastfeeding during the trial treatment period or within 30 days after the last dose of IMP.
29. Clinical laboratory tests suspected cholestasis and serum total bile acid concentration> 3xULN.
The Estimated Number of Participants
-
Taiwan
24 participants
-
Global
750 participants
