Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

Phase 2

Completed

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

• Registration Number: NCT01183169
• Lead Sponsor: Debiopharm International SA

Brief Summary

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-07
• Results First Submitted: 2016-07-14
• Results First Submitted QC: 2016-07-14
• Last Update Submitted: 2016-07-14
• Results First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A: ALV 600 mg QD	Alisporivir	Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Treatment A: ALV 600 mg QD	Ribavirin	Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Treatment C1: ALV Placebo - 600 mg QD	Alisporivir	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Treatment C1: ALV Placebo - 600 mg QD	Placebo	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Treatment C2: ALV Placebo - 400 mg BID	Placebo	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Treatment A: ALV 600 mg QD	Peginterferon alfa-2a	Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Treatment B: ALV 800 mg QD	Peginterferon alfa-2a	Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Treatment B: ALV 800 mg QD	Ribavirin	Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Treatment C1: ALV Placebo - 600 mg QD	Peginterferon alfa-2a	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Treatment C1: ALV Placebo - 600 mg QD	Ribavirin	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Treatment C2: ALV Placebo - 400 mg BID	Peginterferon alfa-2a	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Treatment C2: ALV Placebo - 400 mg BID	Ribavirin	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Treatment D: ALV 400 mg BID	Peginterferon alfa-2a	Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
Treatment D: ALV 400 mg BID	Ribavirin	Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
Treatment B: ALV 800 mg QD	Alisporivir	Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Treatment C2: ALV Placebo - 400 mg BID	Alisporivir	ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Treatment D: ALV 400 mg BID	Alisporivir	Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)	after 12 weeks of treatment	cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Viral Relapse	within 24 weeks after treatment	Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\< LOQ) during treatment.
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)	after 12 weeks of treatment	cEVR-LOD was defined as serum HCV RNA below the limit of detection (\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD	24 weeks after treatment	SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 24 weeks after treatment, respectively.
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD	within 48 weeks	ETR-LOQ and ETR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD at treatment end (completed or prematurely discontinued), respectively.
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End	Up to 48 weeks
Percentage of Participants With On-treatment Viral Breakthrough	within 48 weeks	On-treatment viral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or; * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOQ) during treatment
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD	12 weeks after treatment	SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 12 weeks after treatment, respectively.
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD	after 4 weeks of treatment	RVR-LOQ and RVR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD	after 12 weeks of treatment	pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Nottingham, United Kingdom