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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01728324

Run by

Boehringer Ingelheim

People needed

496

Starts

2012-11-01

Expected to finish

2015-01-01

Last updated by the study team

2016-02-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 1241.36.00020 Boehringer Ingelheim Investigational Site — Anaheim, California, United States
• 1241.36.00005 Boehringer Ingelheim Investigational Site — Bakersfield, California, United States
• 1241.36.00009 Boehringer Ingelheim Investigational Site — La Jolla, California, United States
• 1241.36.00007 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1241.36.00013 Boehringer Ingelheim Investigational Site — Oceanside, California, United States
• 1241.36.00019 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1241.36.00034 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• 1241.36.00022 Boehringer Ingelheim Investigational Site — Bradenton, Florida, United States
• 1241.36.00004 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 1241.36.00006 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 1241.36.00003 Boehringer Ingelheim Investigational Site — Gainesville, Florida, United States
• 1241.36.00010 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 1241.36.00024 Boehringer Ingelheim Investigational Site — Palm Harbor, Florida, United States
• 1241.36.00030 Boehringer Ingelheim Investigational Site — Zephyrhills, Florida, United States
• 1241.36.00027 Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
• 1241.36.00033 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1241.36.00035 Boehringer Ingelheim Investigational Site — Springfield, Illinois, United States
• 1241.36.00001 Boehringer Ingelheim Investigational Site — Valparaiso, Indiana, United States
• 1241.36.00017 Boehringer Ingelheim Investigational Site — Baton Rouge, Louisiana, United States
• 1241.36.00018 Boehringer Ingelheim Investigational Site — Tupelo, Mississippi, United States
• 1241.36.00043 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 1241.36.00032 Boehringer Ingelheim Investigational Site — Hillsborough, New Jersey, United States
• 1241.36.00002 Boehringer Ingelheim Investigational Site — Arlington, Texas, United States
• 1241.36.00039 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
• 1241.36.00016 Boehringer Ingelheim Investigational Site — North Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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