Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

Phase 3

Completed

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

• Registration Number: NCT01318694
• Lead Sponsor: Debiopharm International SA

Brief Summary

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-08
• Results First Submitted: 2016-08-05
• Results First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Results First Posted: 2016-09-30
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1081

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm D	ALV Placebo	ALV Placebo with PEG and RBV for 48 weeks
Treatment Arm A	Peginterferon alfa-2a	Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): * Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks * Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
Treatment Arm A	Ribavirin	Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): * Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks * Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
Treatment Arm B	Peginterferon alfa-2a	Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
Treatment Arm B	Ribavirin	Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
Treatment Arm C	Peginterferon alfa-2a	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
Treatment Arm C	Ribavirin	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
Treatment Arm D	Peginterferon alfa-2a	ALV Placebo with PEG and RBV for 48 weeks
Treatment Arm D	Ribavirin	ALV Placebo with PEG and RBV for 48 weeks
Treatment Arm A	Alisporivir	Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): * Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks * Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
Treatment Arm B	Alisporivir	Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
Treatment Arm C	Alisporivir	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)	12 weeks after the end of treatment	SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the 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 Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)	after 4 weeks of treatment	RVR4 was defined as serum HCV RNA \< LOQ after 4 weeks of treatment.
Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment	after 12 weeks of treatment	cEVR was defined as serum HCV RNA \< LOQ after 12 weeks of treatment.
Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks	within 48 weeks	Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment	after 12 weeks of treatment	EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA \< LOQ after 12 weeks of treatment.
Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment	after 12 weeks of treatment	pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.
Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment	from 4 to 12 weeks of treatment	eRVR was defined as achieving RVR4 and maintaining HCV RNA \< LOQ until Week 12.
Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks	at treatment end within 48 weeks	ETR was defined as serum HCV RNA \< LOQ at treatment end (completed or prematurely discontinued).
Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks	within 48 weeks	ALT abnormalities were summarized as participants who had either: * ALT \> 2 x upper limit of normal (ULN) during the study and \> 2 x ULN at baseline; * ALT \> 3 x ULN during the study and \> 2 x ULN at baseline
Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks	within 48 weeks	Grading was according to the Modified Division of Microbiology \& Infectious Diseases (DMID) Toxicity Tables (version 2.0).; Participants with multiple abnormalities were counted only once in the worst category.
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)	24 weeks after the end of treatment	SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment.
Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks	within 48 weeks	Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh, Vietnam