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

Phase 3

Terminated

• Conditions: Hepatitis C
• Interventions: Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT01500772
• Lead Sponsor: Debiopharm International SA

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-23
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-28
• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2016-05-19
• Results First Submitted QC: 2016-05-19
• Status Verified: 2016-06
• Results First Posted: 2016-06-27
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alisporivir	Alisporivir	ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Alisporivir	Peginterferon alfa-2a	ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Alisporivir	Ribavirin	ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)	12 weeks posttreatment	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)	12 weeks posttreatment	Level of detection (LOD) was defined as 10 IU/mL
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)	24 weeks posttreatment	SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment.
Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events	48 weeks

Trial Locations

Locations (3)

Novartis Investigational Site; 🇩🇪 Mainz, Germany

Novartis Investigative Site; 🇬🇧 London, United Kingdom

Novartis Investigational site; 🇺🇸 Bradenton, Florida, United States