Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV. A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa. This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3. Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)

Key facts

Study ID: NCT01132313
Run by: Boehringer Ingelheim
People needed: 488
Starts: 2010-05-01
Expected to finish: 2014-10-01
Last updated by the study team: 2016-02-01

Who can join

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

You may qualify if…

Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
HCV RNA >=10,000 IU/mL at screening
Liver biopsy within two years or fibroscan within six months prior to baseline
Liver biopsy within two years or fibroscan within 6 months prior to screening
Age 18-75 years

You may not qualify if…

Hepatitis C virus (HCV) infection of mixed genotype
Evidence of liver disease due to causes other than chronic HCV infection
Positive ELISA for human immunodeficiency virus (HIV)
Hepatitis B virus (HBV) infection
Decompensated liver disease or history of decompensated liver disease
Active or suspected malignancy within the last 5 years
Ongoing or historical photosensitivity or recurrent rash
History of alcohol or drug abuse (except cannabis) within the past 12 months
Body mass index (BMI)I <18 or > 35 kg/m2
Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
Known hypersensitivity to any ingredient of the study drugs
A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
AST or ALT >5xULN
INR prolonged to >1.7xULN
Requirement for chronic systemic corticosteroids
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
Contraindications pertaining to PegIFN or RBV

Where it is running

1241.21.0006 Boehringer Ingelheim Investigational Site — San Diego, California, United States
1241.21.0004 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
1241.21.0011 Boehringer Ingelheim Investigational Site — Palm Harbor, Florida, United States
1241.21.0013 Boehringer Ingelheim Investigational Site — Valparaiso, Indiana, United States
1241.21.0008 Boehringer Ingelheim Investigational Site — Springfield, Massachusetts, United States
1241.21.0019 Boehringer Ingelheim Investigational Site — Fayetteville, North Carolina, United States
1241.21.0012 Boehringer Ingelheim Investigational Site — Arlington, Texas, United States
1241.21.0005 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
1241.21.0007 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
1241.21.0010 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
1241.21.0017 Boehringer Ingelheim Investigational Site — Seattle, Washington, United States
1241.21.61002 Boehringer Ingelheim Investigational Site — Heidelberg, Victoria, Australia
1241.21.61001 Boehringer Ingelheim Investigational Site — Melbourne, Victoria, Australia
1241.21.43003 Boehringer Ingelheim Investigational Site — Linz, Austria
1241.21.43001 Boehringer Ingelheim Investigational Site — Vienna, Austria
1241.21.43002 Boehringer Ingelheim Investigational Site — Vienna, Austria
1241.21.33005 Boehringer Ingelheim Investigational Site — Clichy, France
1241.21.33007 Boehringer Ingelheim Investigational Site — Grenoble Cédex 9, France
1241.21.33003 Boehringer Ingelheim Investigational Site — Lyon, France
1241.21.33001 Boehringer Ingelheim Investigational Site — Marseille, France
1241.21.33002 Boehringer Ingelheim Investigational Site — Montpellier, France
1241.21.33004 Boehringer Ingelheim Investigational Site — Paris, France
1241.21.33008 Boehringer Ingelheim Investigational Site — Paris, France
1241.21.33006 Boehringer Ingelheim Investigational Site — Vandœuvre-lès-Nancy, France
1241.21.0003 Boehringer Ingelheim Investigational Site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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