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A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

A Phase III, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN / RBV Treatment

NCT01330316•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic hepatitis C infection of GT-1 in patients who failed prior treatment with PegIFN and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.
•1. Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment \[EOT\]).
•2. Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
•3. Female patients:
•* with documented hysterectomy,
•* who have had both ovaries removed,
•* with documented tubal ligation,
•* who are post-menopausal with last menstrual period at least 12 months prior to screening, or
•* 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 RBV 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 RBV.
•Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.
+5 more criteria

Exclusion Criteria

•2. HIV co-infection
•3. Hepatitis B virus (HBV) infection based on presence of HBs-Ag
•4. 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)
•5. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
•6. 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 patients ability to participate in this study
•7. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
•8. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
•9. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to enrolment and throughout the treatment phase of this trial.
•10. Known hypersensitivity to any ingredient of the study drugs.
•11. 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 randomization (Visit 2).

Locations (87)

1220.48.0004 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1220.48.0091 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

1220.48.0011 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1220.48.0018 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

1220.48.0078 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

1220.48.0095 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

1220.48.0039 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

1220.48.0013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

1220.48.0087 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

1220.48.0027 Boehringer Ingelheim Investigational Site

Framingham, Massachusetts, United States

Key Dates

Start Date

July 1, 2011

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2014

Last Updated

June 30, 2016

Enrollment

119

ACTUAL participants

Conditions

Hepatitis C

Interventions

BI 201335

DRUG

PegIFN/RBV

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 30, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

Inclusion Criteria

Exclusion Criteria

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