Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

Debiopharm

Status and phase: Completed; Phase 2

Conditions: Hepatitis C; Chronic Pain

Treatments: Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: Alisporivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215643

2010-020034-26 (EudraCT Number)

CDEB025A2211

Details and patient eligibility

About

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Enrollment: 340 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C viral infection
• Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
• HCV genotype 2 or 3
• No previous treatment for hepatitis C infection

Exclusion criteria

• Evidence of cirrhosis at the time of screening
• Evidence of hepatocellular carcinoma at the time of screening
• Any other cause of relevant liver disease other than HCV
• Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 5 patient groups

ALV 1000 mg

Experimental group

Description:

Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.

Treatment:

Drug: Alisporivir

ALV 600 mg+RBV

Experimental group

Description:

Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.

Treatment:

Drug: Alisporivir

Drug: Ribavirin

ALV 800 mg+RBV

Experimental group

Description:

Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.

Treatment:

Drug: Alisporivir

Drug: Ribavirin

ALV 600 mg+PEG

Experimental group

Description:

Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.

Treatment:

Drug: Alisporivir

Drug: Peginterferon alfa-2a

PEG+RBV

Active Comparator group

Description:

Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa-2a