Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

Phase 2CompletedNCT02094443

Debiopharm International SA52 enrolled

Overview

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Liver Disease

Interventions

AlisporivirDRUG

ALV 100 and 200 mg soft gel capsules administered orally

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 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon 3. Males or females aged ≥18 years 4. Diagnosed Chronic hepatitis C virus infection Exclusion criteria: 1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 3. Hepatitis B surface antigen (HBsAg) positive 4. Human immunodeficiency virus (HIV) positive Other protocol-defined inclusion/exclusion criteria apply.

Locations (16)

Novartis Investigative Site

Bakersfield, California, United States

Novartis Investigative Site

Lancaster, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12

The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.

Time frame: Baseline, Week 12

Change From Baseline in Alanine Aminotransferase (ALT) at Week 12

ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.

Time frame: Baseline, Week 12

Secondary Outcomes

Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment

SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., \<15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.

Time frame: Up to 24 weeks posttreatment

Percentage of Participants With Extended Rapid Virologic Response

Extended rapid virologic response (eRVR) was defined as serum HCV RNA \< LLOQ after 2 weeks of treatment

Time frame: 2 weeks

Percentage of Participants With Rapid Virologic Response (RVR)

eRVR was defined as serum HCV RNA \< LLOQ after 4 weeks of treatment

Time frame: 4 weeks

Percentage of Participants With End of Treatment Response (ETR)

ETR was defined as serum HCV RNA \< LLOQ at treatment end (completed or prematurely discontinued).

Time frame: Up to 24 weeks

Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End

Data from ClinicalTrials.gov

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