Trial record 3 of 3 for:    HCVerso

Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01728324
First received: November 2, 2012
Last updated: January 14, 2016
Last verified: January 2016
  Purpose
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: BI 207127-placebo: 8-week treatment
Drug: Ribavirin: 24-week treatment
Drug: BI 207127: 24-week treatment
Drug: Faldaprevir: 24-week treatment
Drug: Ribavirin-placebo: 8-week treatment
Drug: Faldaprevir-placebo: 8-week treatment
Drug: Faldaprevir: 16-week treatment
Drug: Ribavirin: 16-week treatment
Drug: RBV: 24-week treatment
Drug: BI 207127: 16-week treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • SVR12 Rates With Historical Control [ Time Frame: 12 Week (post-treatment) ] [ Designated as safety issue: No ]

    Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.

    The number of participants analyzed are actually adjusted number of participant analyzed.


  • Comparisons of SVR12 Rates Across Treatment Arms [ Time Frame: 12 Week (post-treatment) ] [ Designated as safety issue: No ]
    Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.


Secondary Outcome Measures:
  • SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. [ Time Frame: 4 weeks (after End Of Treatment) ] [ Designated as safety issue: No ]
    Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.

  • SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. [ Time Frame: 4 weeks (after End Of Treatment) ] [ Designated as safety issue: No ]
    Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.

  • Prognostic Value of SVR12 Predicting SVR24 [ Time Frame: 24 Week (post-treatment) ] [ Designated as safety issue: No ]
    The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.


Enrollment: 496
Study Start Date: November 2012
Study Completion Date: January 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomised 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
Drug: BI 207127: 24-week treatment
24 weeks of active treatment
Drug: Faldaprevir: 24-week treatment
24 weeks of active treatment
Drug: RBV: 24-week treatment
24 weeks of active treatment
Experimental: Randomised 16-week arm
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
Drug: BI 207127-placebo: 8-week treatment
8 weeks of placebo treatment
Drug: Ribavirin-placebo: 8-week treatment
8 weeks of placebo treatment
Drug: Faldaprevir-placebo: 8-week treatment
8 weeks of placebo treatment
Drug: Faldaprevir: 16-week treatment
16 weeks of active treatment
Drug: Ribavirin: 16-week treatment
16 weeks of active treatment
Drug: BI 207127: 16-week treatment
16 weeks of active treatment
Experimental: Allocated 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
Drug: Ribavirin: 24-week treatment
24 weeks of active treatment
Drug: Faldaprevir: 24-week treatment
24 weeks of active treatment
Drug: BI 207127: 24-week treatment
24 weeks of active treatment

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening
  2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.
  3. HCV viral load =1,000 IU/mL at randomisation.
  4. Patients who have never been previously treated with any other HCV treatment regimen.

Exclusion criteria:

  1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
  3. Liver disease due to causes other than chronic HCV infection.
  4. HIV infection.
  5. Hepatitis B virus infection based on presence of HBs-Ag.
  6. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
  7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
  8. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
  9. Decompensated liver disease, or history of decompensated liver disease.
  10. Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
  11. Red blood cell disorders.
  12. Body weight <40 kg or >125 kg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01728324

  Show 109 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01728324     History of Changes
Other Study ID Numbers: 1241.36  2012-003535-27 
Study First Received: November 2, 2012
Results First Received: January 14, 2016
Last Updated: January 14, 2016
Health Authority: Australia: Human Research Ethics Committee
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
Greece: Ethics Committee
Italy: Ethics Committee
New Zealand: Medsafe
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 30, 2016