Clinical Trials List
2012-09-14 - 2016-12-31
Phase III
Terminated9
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 once daily BI 201335 for 12 or 24 weeks in combination with pegylated interferon-α and ribavirin in treatment-naïve and prior relapser patients with genotype 1 chronic hepatitis C infection.
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Trial Applicant
Boehringer Ingelheim
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chun-Jen Liu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黃惠君 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ming-Lung Yu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 李全膜 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chun-Yen Lin Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chen-Hua Liu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 徐友春 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 牟聯瑞 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma
HCV RNA <25 IU/mL undetected at 12 weeks after the originally planned
treatment duration.
Secondary efficacy endpoints:
Virological response after 24 weeks of treatment discontinuation (SVR24):
Plasma HCV RNA level <25 IU/mL, undetected; 24 weeks after the originally planned treatment duration,
Early Treatment Success (ETS): Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL, undetected at Week 8,
ALT AND AST normalisation. ALT AND AST normal at end of treatment and post treatment.
Inclution Criteria
1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detectable HCV RNA at screening in addition to:
a. Positive anti-HCV antibodies or detectable HCV RNA at least 6 months prior to screening or,
b. Liver biopsy consistent with chronic HCV infection.
2. HCV genotype 1 infection confirmed by genotypic testing at screening.
3. Therapy-naïve to interferon, pegylated interferon, and ribavirin (cohort 1). Or Confirmed prior relapse with an approved dose of PegIFN/RBV(Cohort 2) defined as undetectable HCV RNA (based on an assay considered sensitive at the time of treatment)
at the end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow up,
4. HCV RNA ≥1,000 IU/mL at screening,
5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation.
Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before randomisation need not be repeated. Biopsies may be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy in
patients at risk for the procedure should not exclude such patients from a trial. Subject’s documentation of the last liver biopsy or fibroscan performed will be requested at the screening visit,
6. Age 18 to 70 years,
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
e) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after
the last dose of ribavirin in addition to the consistent and correct use of a condom.
Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.
f) Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, and intra-uterine device.
Exclusion Criteria
1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criterion.
3. HIV co-infection,
4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag,
5. 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. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months,
7. A condition that is defined as one which in the opinion of investigator may put the
patient at risk because of participation in this study, may influence the results of this
study, or limit the patient’s ability to participate in this study,
8. Usage of any investigational drugs within 30 days prior to screening, or planned usage
of an investigational drug during the course of this study,
9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomisation. Patients being treated with oral antivirals such as acyclovir, famiclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened,
10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomisation and throughout the treatment phase.
11. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
12. Known hypersensitivity to any ingredient of the study drugs,
13. 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, CT scan, or MRI) within last 6 months prior to randomisation (Visit 2),
14. Decompensated liver disease, or history of decompensated liver disease, as evidenced by hepatic encephalopathy, ascites, esophageal variceal bleeding, and/or laboratory values which add up to ≥7 points according to the Child-Turcotte-Pugh (CTP) classification (Appendix 10.6).
15. Pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, homicidal ideation, bipolar disorders, mania, a period of disability or impairment due to a psychiatric disease within the past 5 years,
16. Clinical evidence of significant or unstable cardiovascular disease, including angina, myocardial infarction within 6 months, pulmonary hypertension, cardiomyopathy, congestive heart failure, uncontrolled hypertension, significant arrhythmia or clinically significant abnormalities on ECG at screening,
The Estimated Number of Participants
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Taiwan
107 participants
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Global
840 participants
