Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380
• Hepatitis, Chronic 835

Keywords

• Chronic hepatitis C
• Cyclophilin inhibitor

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 8 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Debiopharm International SA is the lead sponsor of 50 studies on the registry; 6 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Study arms

• Experimental
  Alisporivir

  At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy.

  Drug: Alisporivir · Drug: Peginterferon alfa-2a · Drug: Ribavirin

• Active comparator
  Boceprevir

  Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).

  Drug: Boceprevir · Drug: Peginterferon alfa-2a · Drug: Ribavirin

Interventions

• DrugAlisporivir

  ALV 200 mg soft gel capsules administered orally

  Also known as: DEB025

• DrugBoceprevir

  BOC 800 mg (4 x 200 mg soft gel capsules) administered orally

  Also known as: Victrelis®

• DrugPeginterferon alfa-2a

  PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

  Also known as: Pegasys®

• DrugRibavirin

  RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

  Also known as: Copegus®

Primary outcomes

1. Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events

   Time frame: within 48 weeks

Secondary outcomes

1. Percentage of Participants With Emergence of Resistant Mutations

   Time frame: within 48 weeks

2. Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)

   SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.

   Time frame: 24 weeks post-treatment

Baseline characteristics