Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

Phase 3TerminatedNCT01500772

Debiopharm International SA6 enrolled

Overview

This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

AlisporivirDRUG

ALV 200 mg soft gel capsules administered orally

Peginterferon alfa-2aDRUG

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

RibavirinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure 2. Three months minimum time from the last dose of previous PI treatment to the first dose of study medication Exclusion criteria: 1. Use of other investigational drugs at the time of enrollment 2. History of hypersensitivity to PEG or RBV 3. Any null non-responders to prior PEG/RBV treatment Other protocol-defined inclusion/exclusion criteria may apply.

Locations (60)

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)

SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.

Time frame: 12 weeks posttreatment

Secondary Outcomes

Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)

SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment.

Time frame: 24 weeks posttreatment

Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)

Level of detection (LOD) was defined as 10 IU/mL

Time frame: 12 weeks posttreatment

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

Time frame: 48 weeks

Data from ClinicalTrials.gov

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Novartis Investigative Site

Phoenix, Arizona, United States

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Bakersfield, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Ventura, California, United States

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Bradenton, Florida, United States

Novartis Investigative Site

Bradenton, Florida, United States

...and 50 more locations