Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatments pegifn/rbv, bi201335, bi201335 24w, bi 201335
Phase phase 3
Sponsor Boehringer Ingelheim
Start date September 2011
End date September 2013
Trial size 310 participants
Trial identifier NCT01399619, 1220.19, 2010-021734-59

Summary

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
pegifn/rbv
PegIFN/RBV for 24 or 48w
bi201335
BI201335 for 12w
(Experimental)
patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
bi201335 24w
BI201335 for 24w
pegifn/rbv
PegIFN/RBV for 24 or 48w
(Experimental)
patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
pegifn/rbv
PegIFN/RBV for 24 or 48w
bi 201335
BI 201335 for 24 w

Primary Outcomes

Measure
Sustained Virological Response (SVR): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.
time frame: 60 weeks

Secondary Outcomes

Measure
Virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.
time frame: 72 weeks
Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8
time frame: 8 weeks
Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) normalisation: ALT and AST in normal range at end of treatment and post-treatment
time frame: 48 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion criteria: 1. Chronic hepatitis C (HCV) genotype 1 infection 2. Chronic Human Immunodeficiency Virus (HIV) -1 infection 3. HCV treatment naive or HCV treatment experienced but only relapsers 4. Age 18 to 70 years 5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART) 6. Karnofsky score >70 7. HCV viral load >1.000 IU/mL Exclusion criteria: 1. HCV infection of mixed genotype (1/2, 1/3, 1/4) 2. Evidence of acute or chronic liver due to chronic HCV infection 3. Hepatitis B virus (HBV) infection with presence of HBs-Ag 4. Active malignancy or history or malignancy within the last 5 years 5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment. 6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points according tho the Child-Turcotte-Pugh classification 7. Hemoglobin

Additional Information

Official title Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.