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
- PHASE3
- INTERVENTIONAL
Last updated: 2016-06-30
Purpose of Trial
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24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
This study is for people with
Hepatitis C
Interventions being studied
BI 201335
PegIFN/RBV
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.
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).
4. Signed informed consent form prior to trial participation.
Exclusion criteria:
1. 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.
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).
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
20 Locations
Birmingham
1220.48.0004 Boehringer Ingelheim Investigational Site
Alabama, United States
North Little Rock
1220.48.0091 Boehringer Ingelheim Investigational Site
Arkansas, United States
Los Angeles
1220.48.0011 Boehringer Ingelheim Investigational Site
California, United States
Oceanside
1220.48.0018 Boehringer Ingelheim Investigational Site
California, United States
Fort Lauderdale
1220.48.0078 Boehringer Ingelheim Investigational Site
Florida, United States
Palm Harbor
1220.48.0095 Boehringer Ingelheim Investigational Site
Florida, United States
Columbus
1220.48.0039 Boehringer Ingelheim Investigational Site
Georgia, United States
Chicago
1220.48.0013 Boehringer Ingelheim Investigational Site
Illinois, United States
Baton Rouge
1220.48.0087 Boehringer Ingelheim Investigational Site
Louisiana, United States
Framingham
1220.48.0027 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Springfield
1220.48.0065 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Tupelo
1220.48.0023 Boehringer Ingelheim Investigational Site
Mississippi, United States
Neptune
1220.48.0066 Boehringer Ingelheim Investigational Site
New Jersey, United States
New York
1220.48.0012 Boehringer Ingelheim Investigational Site
New York, United States
Portland
1220.48.0058 Boehringer Ingelheim Investigational Site
Oregon, United States
Arlington
1220.48.0063 Boehringer Ingelheim Investigational Site
Texas, United States
Austin
1220.48.0029 Boehringer Ingelheim Investigational Site
Texas, United States
Dallas
1220.48.0017 Boehringer Ingelheim Investigational Site
Texas, United States
Dallas
1220.48.0071 Boehringer Ingelheim Investigational Site
Texas, United States
Forth Worth
1220.48.0081 Boehringer Ingelheim Investigational Site
Texas, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov