Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatments ribavirin (rbv), bi 201335 (faldaprevir), bi 207127, faldaprevir (bi 201335)
Phase phase 3
Sponsor Boehringer Ingelheim
Start date December 2012
End date February 2014
Trial size 475 participants
Trial identifier NCT01732796, 1241.20, 2012-003533-41

Summary

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
Arm
(Experimental)
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
ribavirin (rbv)
24 weeks of active RBV
bi 201335 (faldaprevir)
24 weeks of BI 201335
bi 207127
24 weeks of BI 207127
(Experimental)
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
bi 201335 (faldaprevir)
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
ribavirin (rbv)
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
bi 207127
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
(Experimental)
24 weeks of BI 207127and BI 201335 in combination with RBV
ribavirin (rbv)
24 weeks of active RBV
bi 207127
24 weeks of BI 207127
faldaprevir (bi 201335)
24 weeks of 201335

Primary Outcomes

Measure
Sustained Virologic Response at Week 12 after end of active treatment (SVR 12)
time frame: 12 weeks

Secondary Outcomes

Measure
Sustained Virologic Response at Week 4 after end of active treatment (SVR4)
time frame: 4 weeks after end of active treatment
Sustained Virologic Response at Week 24 after end of active treatment (SVR24)
time frame: 24 weeks after end of active treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion criteria: - Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following: 1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or 2. liver biopsy typical of chronic hepatitis C , or 3. history of elevated ALT at least 6 months prior to screening. - HCV infection of sub-GT1b confirmed by genotypic testing at screening - Treatment naïve defined as: 1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and 2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection - Plasma HCV RNA > or = 1,000 IU/mL at screening - Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included. - Age 18 to 75 years - Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization 1. with documented hysterectomy, or 2. who have had both ovaries removed, or 3. with documented tubal ligation, or 4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or 5. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms. OR: Male patients 1. who are documented to be sterile, or 2. who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and 3. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor). Exclusion criteria: - HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. - HCV subtype 1a, mixed 1a/1b or GT1 undefined - Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease - HIV-1 or HIV-2 infection - Hepatitis B virus (HBV) infection based on presence of HBs-Ag - Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices, - International Normalized Ratio (INR) > or =1.7 - Serum albumin < 3.3 g/dL - Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect ratio >1, unless history of Gilbert's disease - Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) - Patients with ongoing or historical photosensitivity or recurrent rash

Additional Information

Official title A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.