Clinical Trials List
Protocol NumberGS-US-417-0303
NCT Number(ClinicalTrials.gov Identfier)NCT02886728
2016-11-13 - 2021-12-13
Phase III
Terminated9
ICD-9714.0
Rheumatoid arthritis
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
-
Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
-
Sponsor
Gilead Sciences
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- SONG-CHOU HSIEH 無
- CHIH-WEI YU 無
- CHENG-HAN WU 無
- CHIEH-YU SHEN 無
- 郭佑民 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ping-Han Tsai 無
- TianMing Zhan 無
- Shue-Fen Lo 無
- 陳彥輔 無
- Chang-Fu Kuo 無
- 張哲慈 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳勇志 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chen Der-Yuan 無
- 洪偉哲 無
- Jiunn-Horng Chen 無
- Po-Hao Huang 無
- 黃建中 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Rheumatoid Arthritis
Objectives
To evaluate the effects of filgotinib in combination with MTX versus MTX alone for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 24
Test Drug
Filgotinib
Active Ingredient
Filgotinib
Dosage Form
tablet
Dosage
100,200
Endpoints
Criteria for Evaluation:
Safety: Safety will be assessed by documentation of AEs, clinical
laboratory tests, physical examinations, vital signs, and 12-lead
ECGs during the study.
Efficacy: The primary endpoint is:
• The proportion of subjects who achieve an ACR20 response at
Week 24.
The key secondary endpoints are:
• Change from Baseline in the HAQ-DI score at Week 24
• The proportion of subjects who achieve DAS28 [CRP]<2.6 at
Week 24
• Change from Baseline in mTSS at Week 24
Pharmacokinetics: Plasma concentrations of filgotinib and the active metabolite
(GS-829845) will be analyzed.
Safety: Safety will be assessed by documentation of AEs, clinical
laboratory tests, physical examinations, vital signs, and 12-lead
ECGs during the study.
Efficacy: The primary endpoint is:
• The proportion of subjects who achieve an ACR20 response at
Week 24.
The key secondary endpoints are:
• Change from Baseline in the HAQ-DI score at Week 24
• The proportion of subjects who achieve DAS28 [CRP]<2.6 at
Week 24
• Change from Baseline in mTSS at Week 24
Pharmacokinetics: Plasma concentrations of filgotinib and the active metabolite
(GS-829845) will be analyzed.
Inclution Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
1) Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
2) Have a diagnosis of RA (2010 ACR/EULAR criteria) (Appendix 8), and are ACR functional class I-III
3) Have ≥6 swollen joints (from a SJC66) and ≥6 tender joints (from a TJC68) at both
Screening and Day 1 (need not be the same joints) (Appendix 7)
4) Must meet at least one of the following parameters at Screening:
≥1 documented joint erosion on radiographs of the hands, wrists or feet by central
reading
OR
positivity for either RF or anti-CCP Ab (based on central laboratory)
OR
Serum CRP ≥ 4 mg/L (based on central laboratory)
5) Have limited or no prior treatment with MTX, ie, no more than 3 doses of MTX ≤25 mg each in the subject’s lifetime for the treatment of RA, with the last dose at least 28 daysprior to Day 1, and are an appropriate candidate for MTX therapy, as per investigator judgment
6) Females of childbearing potential (as defined in Appendix 5) must have a negative pregnancy test at Screening and Day 1
7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5
8) Lactating female subjects must agree to discontinue nursing from Screening through the end of their study participation.
9) Meet one of the following tuberculosis (TB) Screening criteria:
a) No evidence of active or latent TB:
A negative QuantiFERON® TB-Gold In-Tube test at Screening and
A chest radiograph (views as per local guidelines) taken at Screening or within the
3 months prior to Screening (with the report or films available for investigator
review) without evidence of active or latent TB infection and
No history of either untreated or inadequately treated latent or active TB infection
b) Previously treated for TB: ie, if a subject has previously received an adequate course of therapy as per local standard of care for either latent TB (9 months of isoniazid in a location where rates of primary multi-drug resistant TB infections are <5% or an acceptable alternative regimen) or active TB (acceptable multi-drug regimen). In these cases, no QuantiFERON® TB-Gold In-Tube test (or equivalent assay) need be obtained, but a chest radiograph must be obtained if not done so within 3 months prior to Screening (with the report or films available for investigator review). It is the responsibility of the investigator to verify the adequacy of previous anti-tuberculosis treatment and provide appropriate documentation.
c) Newly identified latent TB during Screening: ie, a subject who has a newly identified positive diagnostic TB test result (defined as a positive QuantiFERON® TB Gold in Tube test [or equivalent assay]) in which active TB has been ruled out and for which appropriate, ongoing, prophylactic treatment for latent tuberculosis has been initiated prior to the first administration of study medication. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised subjects.
Cases falling under category “b” and “c” need to be approved by the Sponsor prior to
enrollment in the study. No subject with currently ACTIVE TB may be enrolled in the
study, regardless of past or present anti-TB medication use.
10) Able and willing to sign the informed consent as approved by the IEC/IRB. Written consent must be provided before initiating any screening evaluations. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the trial, and must be willing to comply with all trial visits and assessments; subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
11) Subjects receiving non-prohibited medication for any reason should be be on a stable dose (defined as no change in prescription) within 7 days or 5 half-lives (whichever is longer)prior to the first administration of study drug on Day 1.
1) Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
2) Have a diagnosis of RA (2010 ACR/EULAR criteria) (Appendix 8), and are ACR functional class I-III
3) Have ≥6 swollen joints (from a SJC66) and ≥6 tender joints (from a TJC68) at both
Screening and Day 1 (need not be the same joints) (Appendix 7)
4) Must meet at least one of the following parameters at Screening:
≥1 documented joint erosion on radiographs of the hands, wrists or feet by central
reading
OR
positivity for either RF or anti-CCP Ab (based on central laboratory)
OR
Serum CRP ≥ 4 mg/L (based on central laboratory)
5) Have limited or no prior treatment with MTX, ie, no more than 3 doses of MTX ≤25 mg each in the subject’s lifetime for the treatment of RA, with the last dose at least 28 daysprior to Day 1, and are an appropriate candidate for MTX therapy, as per investigator judgment
6) Females of childbearing potential (as defined in Appendix 5) must have a negative pregnancy test at Screening and Day 1
7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5
8) Lactating female subjects must agree to discontinue nursing from Screening through the end of their study participation.
9) Meet one of the following tuberculosis (TB) Screening criteria:
a) No evidence of active or latent TB:
A negative QuantiFERON® TB-Gold In-Tube test at Screening and
A chest radiograph (views as per local guidelines) taken at Screening or within the
3 months prior to Screening (with the report or films available for investigator
review) without evidence of active or latent TB infection and
No history of either untreated or inadequately treated latent or active TB infection
b) Previously treated for TB: ie, if a subject has previously received an adequate course of therapy as per local standard of care for either latent TB (9 months of isoniazid in a location where rates of primary multi-drug resistant TB infections are <5% or an acceptable alternative regimen) or active TB (acceptable multi-drug regimen). In these cases, no QuantiFERON® TB-Gold In-Tube test (or equivalent assay) need be obtained, but a chest radiograph must be obtained if not done so within 3 months prior to Screening (with the report or films available for investigator review). It is the responsibility of the investigator to verify the adequacy of previous anti-tuberculosis treatment and provide appropriate documentation.
c) Newly identified latent TB during Screening: ie, a subject who has a newly identified positive diagnostic TB test result (defined as a positive QuantiFERON® TB Gold in Tube test [or equivalent assay]) in which active TB has been ruled out and for which appropriate, ongoing, prophylactic treatment for latent tuberculosis has been initiated prior to the first administration of study medication. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised subjects.
Cases falling under category “b” and “c” need to be approved by the Sponsor prior to
enrollment in the study. No subject with currently ACTIVE TB may be enrolled in the
study, regardless of past or present anti-TB medication use.
10) Able and willing to sign the informed consent as approved by the IEC/IRB. Written consent must be provided before initiating any screening evaluations. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the trial, and must be willing to comply with all trial visits and assessments; subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
11) Subjects receiving non-prohibited medication for any reason should be be on a stable dose (defined as no change in prescription) within 7 days or 5 half-lives (whichever is longer)prior to the first administration of study drug on Day 1.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1) Prior treatments for RA as follows:
a) Alkylating agents, eg, chlorambucil or cyclophosphamide, at any time
b) Previous treatment with any JAK inhibitor
c) Previous therapy with csDMARDs other than MTX or hydroxychloroquine
(eg, gold salts, cyclosporine, leflunomide, azathioprine, sulfasalazine or any other
immunosuppressive).
NOTE: Subjects with prior exposure to csDMARD may be enrolled if the subject had
limited exposure (less than 3 months of total exposure). Washout periods need to be
satisfied per protocol (section 5.4).
d) Use of any licensed or investigational biologic DMARDs (eg, B-cell depleting agents,
tumor necrosis factor (TNF) alpha inhibitors, and/or interleukin (IL)-1, IL-6, IL-17,
IL-12/23 inhibitors, including but not limited to abatacept, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, secukinumab, ustekinumab or tocilizumab
2) Known hypersensitivity or allergy to study drug, its metabolites, or formulation excipients.
3) Known hypersensitivity or allergy to the MTX, its metabolites, or formulation excipients.
4) Oral steroids at a dose >10 mg/day of prednisone (or equivalent) or a prescription for oral steroids which has changed within 4 weeks of Day 1.
5) Receipt of an intra-articular or other injectable corticosteroid within 4 weeks prior to Day 1.
6) Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not been at a stable dose(defined as no change in prescription) for at least 2 weeks prior to Day 1. NOTE: subjects are permitted to take acetylsalicylic acid at a dose of ≤325mg daily for cardiac prophylaxis, or occasional NSAIDs for non-RA indications (eg, headache).
7) Administration of a live/attenuated vaccine within 30 days from Day 1, or planned during the study.
8) Participation in any clinical study of an investigational drug/device within 4 weeks or 5 half-lives prior to Screening, whichever is longer. Exposure to investigational biologics are excluded as outlined in 1d.
9) Have undergone surgical treatments for RA, including synovectomy or arthroplasty in
>4 joints
10) Have any chronic, uncontrolled medical condition, which would put the subject at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per judgment of investigator.
11) Have a history of major surgery (requiring regional block or general anesthesia) within the last 3 months prior to Screening or planned major surgery during the study.
12) Have a moderately to severely active, generalized musculoskeletal disorder that would interfere with assessment of study parameters or increase risk to the subject by participating in the study, eg, generalized osteoarthritis, systemic inflammatory condition other than RA such as, but not limited to: ankylosing spondylitis, reactive arthritis, psoriatic arthritis, inflammatory bowel disease associated arthropathies, systemic lupus erythematosus, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, or gout. Subjects with any history of Felty’s syndrome or juvenile idiopathic arthritis are excluded, regardless of the disease activity level at Screening. (NOTE: subjects with concurrent Sjogren′s syndrome or limited cutaneous vasculitis associated with RA are not excluded, and may be enrolled, based on investigator judgment).
13) Active autoimmune disease other than those listed above, that would interfere with
assessment of study parameters or increase risk to the subject by participating in the study, eg, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis or uveitis.
14) Any known condition or contraindication as addressed in the local labeling or local clinical practice for MTX that would preclude the subject from participating in this study.
15) History of or current moderate to severe congestive heart failure (NYHA class III or IV), or within the last 6 months, a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia new or significant ECG finding at Screening, or any other cardiovascular condition which, in the opinion of the Investigator, would put the subject at risk by participation in the protocol.
16) History of malignancy within the past 5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ with no evidence of recurrence).
17) History of lymphoproliferative disease or current lymphoproliferative disease.
18) History of gastrointestinal perforation.
19) History of organ or bone marrow transplant.
20) Positive serology for human immunodeficiency virus (HIV) 1 or 2.
21) Evidence of active Hepatitis C Virus (HCV) infection. Subjects with positive HCVAb at screening, require reflex testing for HCV RNA. Subjects with positive Hep C RNA viral load (VL) at screening will be excluded. Subjects with positive HCV Ab, but negative HCV RNA VL are eligible per investigator judgment, but require ongoing monitoring as outlined in the schedule of assessments. Subject with active HCV during the study, as evidenced by RNA positivity will be discontinued from study drug as outlined in the protocol.
22) Evidence of active Hepatitis B Virus (HBV) infection. Subjects with positive HBV surface antigen (HBsAg) at screening are excluded from the study. Subjects with positive HBV core Ab and negative HBsAg, require reflex testing for HBV DNA. Subjects with positive HBV DNA at screening will be excluded. Subjects with positive HBV core Ab, and negative HBV DNA are eligible per investigator judgment, but may require prophylactic treatment in accordance with HBV treatment guidelines/local standard of care and require ongoing monitoring with blood tests for HBV DNA every 3 months, as outlined in the schedule of assessments. Subject with evidence of active Hepatitis B during the study, as evidenced by DNA positivity, will be discontinued from study drug as outlined in the protocol.
23) History of opportunistic infection or immunodeficiency syndrome which would put the
subject at risk, as per investigator judgment.
24) Active infection that is clinically significant, as per judgment of the investigator, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of Screening; or any infection requiring oral anti-infective therapy within 30 days of Screening.
25) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria). Past history of disseminated staphylococcus aureus or disseminated Herpes simplex infection.
26) History of symptomatic herpes zoster within 12 weeks prior to Screening or have history of disseminated/complicated herpes zoster infection (multi dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
27) History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ.
28) Current drug, tobacco or alcohol abuse, per investigator judgment.
29) Any condition including active fibromyalgia that based on the investigator’s opinion would make it difficult to appropriately assess RA activity for the purposes of this study.
30) Any condition or circumstances which in the opinion of the Investigator or Sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
31) Use of prohibited medication as outlined in section 5.4
32) Significant blood loss (>450 mL) or transfusion of blood product within 12 weeks prior to Day 1.
33) Tests performed at the central laboratory at Screening that meet any of the criteria below (out of range lab values may be rechecked one time, after consultation with the sponsor or it’s designee, before subject is considered a screen-failure):
a) Hemoglobin <8.0 g/dL (International System of Units [SI]: <80 g/L);
b) White blood cells <3.0 x 103 cells/mm3 (SI: <3.0 x 109 cells/L);
c) Neutrophils <1.5 x 103 cells/mm3 (SI: <1.5 x 109 cells/L);
d) Lymphocytes <0.5 x 103 cells/mm3 (SI: <0.5 x 109 cells/L);
e) Platelets <100 x 103 cells/mm3 (SI: <100 x 109 cells/L);
f) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5x ULN;
g) Total bilirubin level ≥2x ULN unless the subject has been diagnosed with Gilbert’s
disease and this is clearly documented;
h) Estimated creatinine clearance <40 mL/min based on the Cockroft-Gault formula.
1) Prior treatments for RA as follows:
a) Alkylating agents, eg, chlorambucil or cyclophosphamide, at any time
b) Previous treatment with any JAK inhibitor
c) Previous therapy with csDMARDs other than MTX or hydroxychloroquine
(eg, gold salts, cyclosporine, leflunomide, azathioprine, sulfasalazine or any other
immunosuppressive).
NOTE: Subjects with prior exposure to csDMARD may be enrolled if the subject had
limited exposure (less than 3 months of total exposure). Washout periods need to be
satisfied per protocol (section 5.4).
d) Use of any licensed or investigational biologic DMARDs (eg, B-cell depleting agents,
tumor necrosis factor (TNF) alpha inhibitors, and/or interleukin (IL)-1, IL-6, IL-17,
IL-12/23 inhibitors, including but not limited to abatacept, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, secukinumab, ustekinumab or tocilizumab
2) Known hypersensitivity or allergy to study drug, its metabolites, or formulation excipients.
3) Known hypersensitivity or allergy to the MTX, its metabolites, or formulation excipients.
4) Oral steroids at a dose >10 mg/day of prednisone (or equivalent) or a prescription for oral steroids which has changed within 4 weeks of Day 1.
5) Receipt of an intra-articular or other injectable corticosteroid within 4 weeks prior to Day 1.
6) Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not been at a stable dose(defined as no change in prescription) for at least 2 weeks prior to Day 1. NOTE: subjects are permitted to take acetylsalicylic acid at a dose of ≤325mg daily for cardiac prophylaxis, or occasional NSAIDs for non-RA indications (eg, headache).
7) Administration of a live/attenuated vaccine within 30 days from Day 1, or planned during the study.
8) Participation in any clinical study of an investigational drug/device within 4 weeks or 5 half-lives prior to Screening, whichever is longer. Exposure to investigational biologics are excluded as outlined in 1d.
9) Have undergone surgical treatments for RA, including synovectomy or arthroplasty in
>4 joints
10) Have any chronic, uncontrolled medical condition, which would put the subject at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per judgment of investigator.
11) Have a history of major surgery (requiring regional block or general anesthesia) within the last 3 months prior to Screening or planned major surgery during the study.
12) Have a moderately to severely active, generalized musculoskeletal disorder that would interfere with assessment of study parameters or increase risk to the subject by participating in the study, eg, generalized osteoarthritis, systemic inflammatory condition other than RA such as, but not limited to: ankylosing spondylitis, reactive arthritis, psoriatic arthritis, inflammatory bowel disease associated arthropathies, systemic lupus erythematosus, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, or gout. Subjects with any history of Felty’s syndrome or juvenile idiopathic arthritis are excluded, regardless of the disease activity level at Screening. (NOTE: subjects with concurrent Sjogren′s syndrome or limited cutaneous vasculitis associated with RA are not excluded, and may be enrolled, based on investigator judgment).
13) Active autoimmune disease other than those listed above, that would interfere with
assessment of study parameters or increase risk to the subject by participating in the study, eg, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis or uveitis.
14) Any known condition or contraindication as addressed in the local labeling or local clinical practice for MTX that would preclude the subject from participating in this study.
15) History of or current moderate to severe congestive heart failure (NYHA class III or IV), or within the last 6 months, a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia new or significant ECG finding at Screening, or any other cardiovascular condition which, in the opinion of the Investigator, would put the subject at risk by participation in the protocol.
16) History of malignancy within the past 5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ with no evidence of recurrence).
17) History of lymphoproliferative disease or current lymphoproliferative disease.
18) History of gastrointestinal perforation.
19) History of organ or bone marrow transplant.
20) Positive serology for human immunodeficiency virus (HIV) 1 or 2.
21) Evidence of active Hepatitis C Virus (HCV) infection. Subjects with positive HCVAb at screening, require reflex testing for HCV RNA. Subjects with positive Hep C RNA viral load (VL) at screening will be excluded. Subjects with positive HCV Ab, but negative HCV RNA VL are eligible per investigator judgment, but require ongoing monitoring as outlined in the schedule of assessments. Subject with active HCV during the study, as evidenced by RNA positivity will be discontinued from study drug as outlined in the protocol.
22) Evidence of active Hepatitis B Virus (HBV) infection. Subjects with positive HBV surface antigen (HBsAg) at screening are excluded from the study. Subjects with positive HBV core Ab and negative HBsAg, require reflex testing for HBV DNA. Subjects with positive HBV DNA at screening will be excluded. Subjects with positive HBV core Ab, and negative HBV DNA are eligible per investigator judgment, but may require prophylactic treatment in accordance with HBV treatment guidelines/local standard of care and require ongoing monitoring with blood tests for HBV DNA every 3 months, as outlined in the schedule of assessments. Subject with evidence of active Hepatitis B during the study, as evidenced by DNA positivity, will be discontinued from study drug as outlined in the protocol.
23) History of opportunistic infection or immunodeficiency syndrome which would put the
subject at risk, as per investigator judgment.
24) Active infection that is clinically significant, as per judgment of the investigator, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of Screening; or any infection requiring oral anti-infective therapy within 30 days of Screening.
25) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria). Past history of disseminated staphylococcus aureus or disseminated Herpes simplex infection.
26) History of symptomatic herpes zoster within 12 weeks prior to Screening or have history of disseminated/complicated herpes zoster infection (multi dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
27) History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ.
28) Current drug, tobacco or alcohol abuse, per investigator judgment.
29) Any condition including active fibromyalgia that based on the investigator’s opinion would make it difficult to appropriately assess RA activity for the purposes of this study.
30) Any condition or circumstances which in the opinion of the Investigator or Sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
31) Use of prohibited medication as outlined in section 5.4
32) Significant blood loss (>450 mL) or transfusion of blood product within 12 weeks prior to Day 1.
33) Tests performed at the central laboratory at Screening that meet any of the criteria below (out of range lab values may be rechecked one time, after consultation with the sponsor or it’s designee, before subject is considered a screen-failure):
a) Hemoglobin <8.0 g/dL (International System of Units [SI]: <80 g/L);
b) White blood cells <3.0 x 103 cells/mm3 (SI: <3.0 x 109 cells/L);
c) Neutrophils <1.5 x 103 cells/mm3 (SI: <1.5 x 109 cells/L);
d) Lymphocytes <0.5 x 103 cells/mm3 (SI: <0.5 x 109 cells/L);
e) Platelets <100 x 103 cells/mm3 (SI: <100 x 109 cells/L);
f) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5x ULN;
g) Total bilirubin level ≥2x ULN unless the subject has been diagnosed with Gilbert’s
disease and this is clearly documented;
h) Estimated creatinine clearance <40 mL/min based on the Cockroft-Gault formula.
The Estimated Number of Participants
-
Taiwan
50 participants
-
Global
1200 participants
