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

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

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24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

Key facts

Study ID

NCT01330316

Run by

Boehringer Ingelheim

People needed

119

Starts

2011-07-01

Expected to finish

2014-06-01

Last updated by the study team

2016-06-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• or
• Male patients:
• 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.

You may not qualify if…

• 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.

Where it is running

• 1220.48.0063 Boehringer Ingelheim Investigational Site — Arlington, Texas, United States
• 1220.48.0029 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
• 1220.48.0017 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1220.48.0071 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1220.48.0081 Boehringer Ingelheim Investigational Site — Forth Worth, Texas, United States
• 1220.48.4301 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1220.48.4302 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1220.48.3201 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 1220.48.3204 Boehringer Ingelheim Investigational Site — Edegem, Belgium
• 1220.48.3203 Boehringer Ingelheim Investigational Site — Liège, Belgium
• 1220.48.1012 Boehringer Ingelheim Investigational Site — Edmonton, Alberta, Canada
• 1220.48.1003 Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
• 1220.48.1016 Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
• 1220.48.1007 Boehringer Ingelheim Investigational Site — Victoria, British Columbia, Canada
• 1220.48.1009 Boehringer Ingelheim Investigational Site — Winnipeg, Manitoba, Canada
• 1220.48.1005 Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada
• 1220.48.1006 Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada
• 1220.48.3301 Boehringer Ingelheim Investigational Site — Clichy, France
• 1220.48.3311 Boehringer Ingelheim Investigational Site — Lille, France
• 1220.48.3303 Boehringer Ingelheim Investigational Site — Marseille, France
• 1220.48.3304 Boehringer Ingelheim Investigational Site — Montpellier, France
• 1220.48.3305 Boehringer Ingelheim Investigational Site — Nice, France
• 1220.48.3316 Boehringer Ingelheim Investigational Site — Pessac, France
• 1220.48.3312 Boehringer Ingelheim Investigational Site — Saint-Laurent-du-Var, France
• 1220.48.0058 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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