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OpenTrials
Completed

NCT Number: NCT01728324

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1241.36.61005 Boehringer Ingelheim Investigational Site, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  • HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
  • Liver disease due to causes other than chronic HCV infection.
  • HIV infection.
  • Hepatitis B virus infection based on presence of HBs-Ag.
  • Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
  • History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
  • 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).
  • Decompensated liver disease, or history of decompensated liver disease.
  • Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
  • Red blood cell disorders.
  • Body weight <40 kg or >125 kg.

Treatment and study plan

BI 207127-placebo: 8-week treatment

Drug

8 weeks of placebo treatment

Ribavirin: 24-week treatment

Drug

24 weeks of active treatment

BI 207127: 24-week treatment

Drug

24 weeks of active treatment

Faldaprevir: 24-week treatment

Drug

24 weeks of active treatment

Ribavirin-placebo: 8-week treatment

Drug

8 weeks of placebo treatment

Faldaprevir-placebo: 8-week treatment

Drug

8 weeks of placebo treatment

Faldaprevir: 16-week treatment

Drug

16 weeks of active treatment

Ribavirin: 16-week treatment

Drug

16 weeks of active treatment

RBV: 24-week treatment

Drug

24 weeks of active treatment

BI 207127: 16-week treatment

Drug

16 weeks of active treatment

Primary outcomes

  1. SVR12 Rates With Historical Control

    Time frame: 12 Week (post-treatment)

    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.

  2. Comparisons of SVR12 Rates Across Treatment Arms

    Time frame: 12 Week (post-treatment)

    Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.

Secondary outcomes

  1. SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.

    Time frame: 4 weeks (after End Of Treatment)

    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.

  2. SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.

    Time frame: 4 weeks (after End Of Treatment)

    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.

  3. Prognostic Value of SVR12 Predicting SVR24

    Time frame: 24 Week (post-treatment)

    The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 19, 2012
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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