Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Status and phase
Completed
Phase 2
Conditions
Hepatitis C
Treatments
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: Alisporivir
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.
Enrollment
459 patients
Sex
All
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Chronic HCV genotype 1 viral infection
- HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
- Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks
Exclusion criteria
- Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
- Women of child-bearing potential unless using highly effective
- Any other cause of relevant liver disease other than HCV
- Other protocol-defined inclusion/exclusion criteria may apply
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
459 participants in 5 patient groups
Treatment A: ALV 600 mg QD
Experimental group
Description:
Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Treatment:
Drug: Alisporivir
Drug: Ribavirin
Drug: Peginterferon alfa-2a
Treatment B: ALV 800 mg QD
Experimental group
Description:
Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Treatment:
Drug: Alisporivir
Drug: Ribavirin
Drug: Peginterferon alfa-2a
Treatment C1: ALV Placebo - 600 mg QD
Experimental group
Description:
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Treatment:
Drug: Placebo
Drug: Alisporivir
Drug: Ribavirin
Drug: Peginterferon alfa-2a
Treatment C2: ALV Placebo - 400 mg BID
Experimental group
Description:
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Treatment:
Drug: Placebo
Drug: Alisporivir
Drug: Ribavirin
Drug: Peginterferon alfa-2a
Treatment D: ALV 400 mg BID
Experimental group
Description:
Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
Treatment:
Drug: Alisporivir
Drug: Ribavirin
Drug: Peginterferon alfa-2a
Trial contacts and locations
75
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Data sourced from clinicaltrials.gov
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