Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

Debiopharm

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318694

CDEB025A2301

2010-022867-37 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Enrollment: 1,081 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HCV infection
• HCV genotype 1
• No previous treatment for hepatitis C infection
• Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
• Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

Exclusion criteria

• HCV genotype different from genotype 1 or co-infection with other HCV genotype
• Co-infection with Hepatitis B or HIV
• Any other cause of relevant liver disease other than HCV
• Presence or history of hepatic decompensation
• Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (> ULN) in past 6 months

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,081 participants in 4 patient groups

Treatment Arm A

Experimental group

Description:

Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): * Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks * Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment

Treatment:

Drug: Alisporivir

Drug: Peginterferon alfa-2a

Drug: Ribavirin

Treatment Arm B

Experimental group

Description:

Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)

Treatment:

Drug: Alisporivir

Drug: Peginterferon alfa-2a

Drug: Ribavirin

Treatment Arm C

Experimental group

Description:

Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks

Treatment:

Drug: Alisporivir

Drug: Peginterferon alfa-2a

Drug: Ribavirin

Treatment Arm D

Active Comparator group

Description:

ALV Placebo with PEG and RBV for 48 weeks

Treatment:

Drug: Peginterferon alfa-2a

Drug: Ribavirin

Drug: ALV Placebo