Clinical Trials List
Protocol Number1220.47
2011-04-07 - 2014-05-31
Phase III
Terminated5
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
- Chen-Hua Liu Digestive System Department
- PEI-JER CHEN Digestive System Department
- 蘇東弘 Digestive System Department
- 楊宏志 Digestive System Department
- Chun-Jen Liu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 李全膜 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hsueh-Chou Lai Digestive System Department
- 陳昇弘 Digestive System Department
- 高榮達 Digestive System Department
- 蘇文邦 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Hepatitis C virus
Objectives
To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (240 mg given for 12 weeks or BI 201335 120 mg given for 24 weeks both in combination with PegIFN/RBV as compared to PegIFN/RBV alone in treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.
Test Drug
BI 201335
Active Ingredient
BI 201335
Dosage Form
Dosage
120
Endpoints
rimary efficacy endpoint:
Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma HCV RNA <25 IU/mL undetected at 12 weeks after the originally planned treatment duration.
Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma HCV RNA <25 IU/mL undetected at 12 weeks after the originally planned treatment duration.
Inclution Criteria
1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and
detected HCV RNA at screening in addition to:
(a) Positive anti-HCV antibodies or detected 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
Prior relapse 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 liver biopsy within 3 years or fibroscan within 6 months
prior to randomisation,
Subject’s documentation of the liver biopsy or fibroscan performed will be
requested at the screening visit,
6. Age 18 to 70 years,
7. Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.
or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.
8. Signed informed consent form prior to trial participation
detected HCV RNA at screening in addition to:
(a) Positive anti-HCV antibodies or detected 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
Prior relapse 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 liver biopsy within 3 years or fibroscan within 6 months
prior to randomisation,
Subject’s documentation of the liver biopsy or fibroscan performed will be
requested at the screening visit,
6. Age 18 to 70 years,
7. Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.
or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.
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. 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,
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
0 participants
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Global
0 participants
