Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)
This study has been completed.
Information provided by (Responsible Party):
First received: April 20, 2011
Last updated: March 27, 2014
Last verified: March 2014
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
Drug: BI 201335
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
Primary Outcome Measures:
- Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma HCV RNA level < 25 IU/mL, undetected 12 weeks after the originally planned treatment duration. [ Time Frame: 72 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: 60 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 and Aspartate Aminotransferase normalisation: Alanine Aminotransferase and Aspartate Aminotransferase in normal range at end of treatment and post-treatment [ Time Frame: 48 & 72 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Active Comparator: PegIFN/RBV
PegIFN/RBV for 48 weeks
PegIFN/RBV for 48 weeks
Experimental: BI 201335 for 12 or 24 weeks
BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Drug: BI 201335
BI 201335 once daily low dose
Experimental: BI 201335 for 12 weeks
BI 201335 once daily high dose for 12 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Drug: BI 201335
BI 201335 once daily high dose
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
- positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
- liver biopsy consistent with chronic HCV infection.
- HCV genotype 1 infection confirmed by genotypic testing at screening.
- Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
- HCV RNA = 1,000 IU/mL at screening
Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomization.
Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before randomization need not be repeated. Biopsies may be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy in patients at risk for the procedure should not exclude such patients from a trial.
- Age 18 to 70 years
- 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 ribavirin 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 ribavirin.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol containing contraceptives, diaphragm with spermicide substance and intra-uterine device.
- 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) 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 should 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
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
- 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.
- 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 randomization. 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 randomization 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01343888
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 20, 2011
||March 27, 2014
||Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action