A Phase III, Randomised, Open Label, Active-controlled Study of an Interferon-free Regimen of BI 207127 in Combination With Faldaprevir and Ribavirin Compared to Telaprevir in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive Patients With Chronic Genotype 1b Hepatitis C Virus Infection
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Boehringer Ingelheim
- Locations
- 12
- Primary Endpoint
- Sustained Virologic Response at Week 12 after end of treatment (SVR12)
Study Overview
Brief Summary
The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
BI 201335 in combination with BI 207127 and ribavirin for 24 weeks
Intervention: BI 201335 (Drug)
Group 2
Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks
Intervention: Pegylated Interferon (Drug)
Group 1
BI 201335 in combination with BI 207127 and ribavirin for 24 weeks
Intervention: ribavirin (Drug)
Group 1
BI 201335 in combination with BI 207127 and ribavirin for 24 weeks
Intervention: BI 207127 (Drug)
Group 2
Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks
Intervention: Telaprevir (Drug)
Group 2
Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks
Intervention: ribavirin (Drug)
Outcomes
Primary Outcomes
Sustained Virologic Response at Week 12 after end of treatment (SVR12)
Time Frame: at week 12 post treatment
Secondary Outcomes
- Lack of on-treatment viral response(up to week 48)
- Relapse(up to 48 weeks post treatment)
- SVR4: Plasma HCV RNA level <25 IU/mL1 at 4 weeks after end of treatment(at week 4 post treatment)
- SVR24: Plasma HCV RNA level <25 IU/mL1 at 24 weeks after end of treatment(at week 4 post treatment)
- Virological Response at Week 4 -Plasma HCV RNA level undetectable at Week 4 -Plasma HCV RNA level <25 IU/mL at Week 4(at week 4 post treatment)
- Serious Adverse Events(up to week 48 post treatment)
- Laboratory test abnormalities by DAIDS grades(up to week 48 post treatment)
- Rate of red blood cell transfusion(up to week 48 post treatment)
- Time to discontinuation of trial medication(up to week 48)
- Plasma HCV level undetectable at Week 12(at week 12)
- Time to achieving HCV RNA undetectable(up to week 48)
- Adverse events(up to week 48 post treatment)
- Adverse events leading to discontinuation(up to week 48)
- Liver disease progression, fibroscan and FibroSURE(up to week 48 post treatment)
- Rate of ESA use(up to week 48 post treatment)
- Change in laboratory test values over time(up to week 48 post treatment)
- Patients requiring hospitalisation due to AEs related to study drugs(up to week 48 post treatment)
- Virological breakthrough(up to week 48)
- ETR: Plasma HCV RNA level undetected at the end of treatment(week 24 or 48)