Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
- NCT01132313
- PHASE2
- INTERVENTIONAL
Last updated: 2016-02-01
Purpose of Trial
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)
This study is for people with
Hepatitis C, Chronic
Interventions being studied
BI 207127
BI 201335
BI 207127
BI 201335
Ribavirin
Ribavirin
Ribavirin
BI 207127
BI 207127
BI 207127
BI 201335
Ribavirin
Ribavirin
BI 207127
BI 207127
BI 201335
BI 201335
Ribavirin
BI 201335
BI 201335
BI 207127
BI 201335
BI 201335
BI 207127
BI 201335
Ribavirin
Ribavirin
BI 207217
BI 201335
BI 207127
Ribavirin
BI 207127
BI 201335
Ribavirin
Ribavirin
Inclusion criteria:
* 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
Exclusion criteria:
* 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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
12 Locations
La Jolla
1241.21.0003 Boehringer Ingelheim Investigational Site
California, United States
San Diego
1241.21.0006 Boehringer Ingelheim Investigational Site
California, United States
San Francisco
1241.21.0004 Boehringer Ingelheim Investigational Site
California, United States
Palm Harbor
1241.21.0011 Boehringer Ingelheim Investigational Site
Florida, United States
Valparaiso
1241.21.0013 Boehringer Ingelheim Investigational Site
Indiana, United States
Springfield
1241.21.0008 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Fayetteville
1241.21.0019 Boehringer Ingelheim Investigational Site
North Carolina, United States
Arlington
1241.21.0012 Boehringer Ingelheim Investigational Site
Texas, United States
Austin
1241.21.0005 Boehringer Ingelheim Investigational Site
Texas, United States
Dallas
1241.21.0007 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1241.21.0010 Boehringer Ingelheim Investigational Site
Texas, United States
Seattle
1241.21.0017 Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov