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

Phase 2

Completed

• Conditions: Hepatitis C; Liver Disease
• Interventions: Drug: Alisporivir; Drug: Ribavirin

• Registration Number: NCT02094443
• Lead Sponsor: Debiopharm International SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-06-30
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-19
• Last Update Submitted: 2016-08-19
• Results First Posted: 2016-10-13
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alisporivir 300 mg BID	Alisporivir	Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Alisporivir 400 mg BID	Ribavirin	ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Alisporivir 300 mg BID	Ribavirin	Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Alisporivir 400 mg BID	Alisporivir	ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12	Baseline, Week 12	The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment	Up to 24 weeks posttreatment	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.
Percentage of Participants With Extended Rapid Virologic Response	2 weeks	Extended rapid virologic response (eRVR) was defined as serum HCV RNA \< LLOQ after 2 weeks of treatment
Percentage of Participants With Rapid Virologic Response (RVR)	4 weeks	eRVR was defined as serum HCV RNA \< LLOQ after 4 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR)	Up to 24 weeks	ETR was defined as serum HCV RNA \< LLOQ at treatment end (completed or prematurely discontinued).
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End	Up to 24 weeks	ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Paris, France