Clinical Trials List
Protocol Number1241.41
NCT Number(ClinicalTrials.gov Identfier)NCT01728324
2013-06-01 - 2014-12-31
Phase III
Terminated10
ICD-10B17.10
Acute hepatitis C without hepatic coma
ICD-10B19.20
Unspecified viral hepatitis C without hepatic coma
ICD-9070.51
Hepatitis C without mention of hepatic coma, acute or unspecified
A phase III randomised, double-blind and placebo-controlled study of BI 207127 NA in combination with faldaprevir and ribavirin for chronic genotype 1b hepatitis C virus infection in an extended population of treatment naïve patients that includes those ineligible to receive peginterferon
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 曾柏霖 Division of General Internal Medicine
- 戴維震 Division of General Internal Medicine
- 張國欽 Division of General Internal Medicine
- 陳建宏 Division of General Internal Medicine
- Jing-Houng Wang Division of General Internal Medicine
- 紀廣明 Division of General Internal Medicine
- 洪肇宏 Division of General Internal Medicine
- 顏毅豪 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Jee-Fu Huang Division of General Internal Medicine
- Ming-Lun Yeh Division of General Internal Medicine
- Ming-Lung Yu Division of General Internal Medicine
- Chia-Yen Dai Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳威廷 Division of General Internal Medicine
- Chien-Hao Huang Division of General Internal Medicine
- Chun-Yen Lin Division of General Internal Medicine
- Wen-Juei Jeng Division of General Internal Medicine
- Yi-Cheng Chen Division of General Internal Medicine
- 張子晉 Division of General Internal Medicine
- Chen-Chun Lin Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 李少武 Division of General Internal Medicine
- 葉宏仁 Division of General Internal Medicine
- CHUNG-HSIN CHANG Division of General Internal Medicine
- TENG-YU LEE Division of General Internal Medicine
- 呂宜達 Division of General Internal Medicine
- 童春芳 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳介章 Division of General Internal Medicine
- Chen-Hua Liu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 徐友春 Division of General Internal Medicine
- 范泉山 Division of General Internal Medicine
- 顏旭亨 Division of General Internal Medicine
- 周昆慶 Division of General Internal Medicine
- 吳順生 Division of General Internal Medicine
- 蘇培元 Division of General Internal Medicine
- 楊佳偉 Division of General Internal Medicine
- 施凱倫 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳昇弘 Division of General Internal Medicine
- 蘇文邦 Division of General Internal Medicine
- 高榮達 Division of General Internal Medicine
- Hsueh-Chou Lai Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- PEI-JER CHEN Division of General Internal Medicine
- 蘇東弘 Division of General Internal Medicine
- Chen-Hua Liu Division of General Internal Medicine
- KAI-WEN HUANG Division of General Internal Medicine
- 楊宏志 Division of General Internal Medicine
- Chun-Jen Liu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Hepatitis C virus
Objectives
The aim of the study is to confirm efficacy and safety of treatment with BI 207127 NA 600 mg BID (Bis in die) in combination with faldaprevir (FDV) 80 mg QD (Quaque in die) and ribavirin (RBV) for 16 or 24 weeks in chronically infected hepatitis C virus (HCV) genotype (GT) 1b treatment naïve patients, including patients with compensated cirrhosis in Japan, Korea and Taiwan.
The primary objective is to determine if the threshold sustained virologic response (SVR) rates derived from an approved direct acting anti-viral (DAA) data in combination with pegylated interferon- alfa (PegIFN) can be achieved by the combination treatments of BI 207127 NA, FDV and RBV for 16 week and 24 week, and to determine if there is a clinically meaningful difference between 16- and 24-week treatment durations
Test Drug
BI 207127 , Faldaprevir (BI 201335 NA)
Active Ingredient
BI 207127
Faldaprevir
Faldaprevir
Dosage Form
capsule
tablet
tablet
Dosage
200
40
40
Endpoints
Primary efficacy endpoint:
• Sustained Virologic Response at Week 12 after end of active treatment (SVR12):
Plasma HCV RNA level <25 IU/mL at 12 weeks after end of active treatment.
Secondary efficacy endpoints:
• SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after end of active
treatment.
• SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after end of active
treatment.
• Relapse: HCV RNA level >25 IU/mL during the post-active treatment period in
patients who had End of Treatment Response (ETRTND) after the completing the
planned active treatment duration.
Further efficacy endpoints:
• Virological Response (VR) at Week 4:
-Plasma HCV RNA undetected at Week 4 (W4UTND)
-Plasma HCV RNA level <25 IU/mL at Week 4 (W4U)
• Plasma HCV RNA undetected at Week 12 (W12UTND)
• Plasma HCV RNA undetected at 24 weeks after end of active treatment
(SVR24TND)
• End of Treatment Response: Plasma HCV RNA undetected at end of all therapy
(ETRTND)
• Time to achieving HCV RNA undetected
• Virologic breakthrough (as defined in Section 3.3.4.1)
• Lack of on-treatment viral response (as defined in Section 3.3.4.1)
• Time to virologic breakthrough (from nadir and undetected)
• Biochemical response
-ALT and aspartate aminotransferase (AST) in normal range at end of
treatment (EOT)
-ALT and AST in normal range post-treatment
FibroSURETM and AST to platelet ratio index (APRI score)
• Sustained Virologic Response at Week 12 after end of active treatment (SVR12):
Plasma HCV RNA level <25 IU/mL at 12 weeks after end of active treatment.
Secondary efficacy endpoints:
• SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after end of active
treatment.
• SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after end of active
treatment.
• Relapse: HCV RNA level >25 IU/mL during the post-active treatment period in
patients who had End of Treatment Response (ETRTND) after the completing the
planned active treatment duration.
Further efficacy endpoints:
• Virological Response (VR) at Week 4:
-Plasma HCV RNA undetected at Week 4 (W4UTND)
-Plasma HCV RNA level <25 IU/mL at Week 4 (W4U)
• Plasma HCV RNA undetected at Week 12 (W12UTND)
• Plasma HCV RNA undetected at 24 weeks after end of active treatment
(SVR24TND)
• End of Treatment Response: Plasma HCV RNA undetected at end of all therapy
(ETRTND)
• Time to achieving HCV RNA undetected
• Virologic breakthrough (as defined in Section 3.3.4.1)
• Lack of on-treatment viral response (as defined in Section 3.3.4.1)
• Time to virologic breakthrough (from nadir and undetected)
• Biochemical response
-ALT and aspartate aminotransferase (AST) in normal range at end of
treatment (EOT)
-ALT and AST in normal range post-treatment
FibroSURETM and AST to platelet ratio index (APRI score)
Inclution Criteria
Inclusion criteria
1. Chronic hepatitis C virus infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to at least one of the following:
a. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, or
b. liver biopsy indicating chronic HCV infection, or
c. elevated ALT levels for at least 6 months prior to screening.
2. HCV GT1b infection confirmed by genotypic testing at screening
3. HCV viral load ≥1000 IU/mL at screening.
4. Patients who have never been previously treated with interferon alone, interferon+RBV,PegIFN+RBV or PegIFN+RBV+an investigational/approved DAA or any other HCV treatment regimen.
5. Availability of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation.
6. Age 20 to 75 years (inclusive).
7. Female patients:
a. with documented hysterectomy,
b. who have had both ovaries removed,
c. with documented tubal ligation,
d. who are post-menopausal with last menstrual period at least 12 months prior to
screening, or
and a negative urine pregnancy test on Day 1 (Visit 2) prior to randomisation
or
e. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2) , that agree to use two nonhormonal methods of birth control from the date of screening until 6 months after the last dose of RBV. Patients must agree not to breast-feed at any time from the date of screening until 6 months after the last dose of RBV.
Accepted methods of contraception in the study include diaphragm with spermicidal substance, intrauterine devices and condoms.
Male patients:
a. who are documented to be sterile, or
b. who consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) agree with use one of the appropriate medically accepted methods of birth control from the date of screening until 6 months after the last dose of RBV, and
c. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and the follow-up phase.
Female partners of childbearing potential should perform monthly pregnancy tests from the date of screening until 6 months after the last dose of RBV (tests will be provided by the sponsor).
8. Signed informed consent form prior to trial participation
1. Chronic hepatitis C virus infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to at least one of the following:
a. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, or
b. liver biopsy indicating chronic HCV infection, or
c. elevated ALT levels for at least 6 months prior to screening.
2. HCV GT1b infection confirmed by genotypic testing at screening
3. HCV viral load ≥1000 IU/mL at screening.
4. Patients who have never been previously treated with interferon alone, interferon+RBV,PegIFN+RBV or PegIFN+RBV+an investigational/approved DAA or any other HCV treatment regimen.
5. Availability of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation.
6. Age 20 to 75 years (inclusive).
7. Female patients:
a. with documented hysterectomy,
b. who have had both ovaries removed,
c. with documented tubal ligation,
d. who are post-menopausal with last menstrual period at least 12 months prior to
screening, or
and a negative urine pregnancy test on Day 1 (Visit 2) prior to randomisation
or
e. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2) , that agree to use two nonhormonal methods of birth control from the date of screening until 6 months after the last dose of RBV. Patients must agree not to breast-feed at any time from the date of screening until 6 months after the last dose of RBV.
Accepted methods of contraception in the study include diaphragm with spermicidal substance, intrauterine devices and condoms.
Male patients:
a. who are documented to be sterile, or
b. who consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) agree with use one of the appropriate medically accepted methods of birth control from the date of screening until 6 months after the last dose of RBV, and
c. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and the follow-up phase.
Female partners of childbearing potential should perform monthly pregnancy tests from the date of screening until 6 months after the last dose of RBV (tests will be provided by the sponsor).
8. Signed informed consent form prior to trial participation
Exclusion Criteria
Exclusion criteria
1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
2. Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases. Note:patients with steatosis as part of the histological findings of the liver biopsy are not excluded.
3. HIV infection.
4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
5. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
6. History of illicit drug abuse or chronic alcohol abuse within 12 months prior to screening.
7. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis) by investigator’s directions.
8. A condition that is insufficiently diagnosed, treated or clinically unstable which in the opinion of investigator may put the patient at risk because of participation in this study, influence the results of this study, or limit the patient’s ability to participate in this study, including but not limited to severe chronic obstructive pulmonary disease, uncontrolled psychiatric disease.
9. Decompensated liver disease (Child-Turcotte-Pugh class B and C, see Section 10.4), or history of decompensated liver disease, as evidenced by ascites, hepatic encephalopathy, history of esophageal variceal bleeding, or any other evidence of previous decompensation.
10. Total bilirubin >2 mg/dL with ratio of direct/indirect >1 at creening.
11. Serum albumin ≤3.3 g/dL at screening.
12. Prothrombin time International Normalised Ratio (INR) ≥1.7 at screening.
13. Clinical evidence of unstable cardiovascular disease which may further decompensate
due to anemia, including unstable angina, myocardial infarction within 6 months prior to
screening, cardiomyopathy, congestive heart failure, uncontrolled hypertension or
significant arrhythmia.
14. Red blood cell (RBC) disorders which include but are not limited to: thalassemia major,
sickle cell anemia or G6PD deficit. Patients with traits or minor diseases (e.g. sickle cell trait or thalassemia minor) may be enrolled if the disease did not result in anemia at screening, according to the investigator’s clinical judgment.
15. Body weight <40 kg or >125 kg at screening.
16. Usage of any investigational drugs within 28 days prior to randomisation, or planned usage of an investigational drug during the course of this study.
17. Received concomitant hematopoietic growth factor within 28 days prior to randamisation.
18. Received silymarin (milk thistle), glycyrrhizin, Sho-saiko-to (SST) or any medication listed in a restricted medication list provided in ISF within 28 days prior to randomisation, with the exception of parenteral analgesics used during liver biopsy procedure.
19. Known history of hypersensitivity to other nucleoside analogue such as acyclovir, ganciclovir and vidarabine.
20. Known hypersensitivity to any ingredient of the study drugs.
21. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and ≤100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, computer tomography (CT) scan, or Magnetic Resonance Imaging (MRI)) within last 6 months prior to randomisation.
22. Haemoglobin <11 g/dL for women and <12 g/dL for men at screening.
23. Absolute neutrophil count <1000 cells/mm3 at screening.
24. Platelet count <70000 cells/mm3 at screening.
1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
2. Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases. Note:patients with steatosis as part of the histological findings of the liver biopsy are not excluded.
3. HIV infection.
4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
5. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
6. History of illicit drug abuse or chronic alcohol abuse within 12 months prior to screening.
7. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis) by investigator’s directions.
8. A condition that is insufficiently diagnosed, treated or clinically unstable which in the opinion of investigator may put the patient at risk because of participation in this study, influence the results of this study, or limit the patient’s ability to participate in this study, including but not limited to severe chronic obstructive pulmonary disease, uncontrolled psychiatric disease.
9. Decompensated liver disease (Child-Turcotte-Pugh class B and C, see Section 10.4), or history of decompensated liver disease, as evidenced by ascites, hepatic encephalopathy, history of esophageal variceal bleeding, or any other evidence of previous decompensation.
10. Total bilirubin >2 mg/dL with ratio of direct/indirect >1 at creening.
11. Serum albumin ≤3.3 g/dL at screening.
12. Prothrombin time International Normalised Ratio (INR) ≥1.7 at screening.
13. Clinical evidence of unstable cardiovascular disease which may further decompensate
due to anemia, including unstable angina, myocardial infarction within 6 months prior to
screening, cardiomyopathy, congestive heart failure, uncontrolled hypertension or
significant arrhythmia.
14. Red blood cell (RBC) disorders which include but are not limited to: thalassemia major,
sickle cell anemia or G6PD deficit. Patients with traits or minor diseases (e.g. sickle cell trait or thalassemia minor) may be enrolled if the disease did not result in anemia at screening, according to the investigator’s clinical judgment.
15. Body weight <40 kg or >125 kg at screening.
16. Usage of any investigational drugs within 28 days prior to randomisation, or planned usage of an investigational drug during the course of this study.
17. Received concomitant hematopoietic growth factor within 28 days prior to randamisation.
18. Received silymarin (milk thistle), glycyrrhizin, Sho-saiko-to (SST) or any medication listed in a restricted medication list provided in ISF within 28 days prior to randomisation, with the exception of parenteral analgesics used during liver biopsy procedure.
19. Known history of hypersensitivity to other nucleoside analogue such as acyclovir, ganciclovir and vidarabine.
20. Known hypersensitivity to any ingredient of the study drugs.
21. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and ≤100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, computer tomography (CT) scan, or Magnetic Resonance Imaging (MRI)) within last 6 months prior to randomisation.
22. Haemoglobin <11 g/dL for women and <12 g/dL for men at screening.
23. Absolute neutrophil count <1000 cells/mm3 at screening.
24. Platelet count <70000 cells/mm3 at screening.
The Estimated Number of Participants
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Taiwan
52 participants
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Global
459 participants
