A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
This study has been completed.
Information provided by (Responsible Party):
First received: April 5, 2011
Last updated: July 23, 2014
Last verified: July 2014
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24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
Drug: BI 201335
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Sustained Virological Response (SVR): Plasma HCV RNA level < 25 IU/mL, undetected 12 weeks after the originally planned treatment duration. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Alanine Aminotransferase normalisation: Alanine Aminotransferase in normal range 24 weeks after end of the originally planned treatment duration. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Occurrence of Adverse Events (overall and by DAIDS grade) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Occurrence of Adverse Events leading to treatment discontinuation [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Occurrence of drug-related AEs as assessed by the Investigator [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Occurrence of laboratory test abnormalities [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in laboratory test values over time [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Aspartate Aminotransferase normalisation: Aspartate Aminotransferase in normal range 24 weeks after end of the originally planned treatment duration. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Experimental: BI 201335 for 24 weeks
BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Drug: BI 201335
BI 201335 for 24 weeks
PegIFN/RBV for 48 weeks
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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]).
- Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
- 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.
- who are documented to be sterile, or
- who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) 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. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
- Signed informed consent form prior to trial participation.
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria.
- HIV co-infection
- Hepatitis B virus (HBV) infection based on presence of HBs-Ag
- 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)
- Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
- 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
- Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
- 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.
- Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to enrolment and throughout the treatment phase of this trial.
- Known hypersensitivity to any ingredient of the study drugs.
- 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).
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330316
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 5, 2011
||July 23, 2014
||Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
France: Agence Nationale sécurité médicament et des produits santé
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections