Alisporivir With pegIFN/RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01500772

First received: December 23, 2011

Last updated: May 4, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 23, 2011

Last Updated Date

May 4, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

SVR12 [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]

SVR12 is defined as HCV RNA laboratory value <LOQ, (Level of quantification) 12 weeks after the end of treatment. The assay used in this study has a reported LOQ of 25 IU/ml.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01500772 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SVR24 [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
SVR24 is defined as HCV RNA laboratory value <LOQ, (Level of quantification) 24 weeks after the end of treatment. The assay used in this study has a reported LOQ of 25 IU/ml
SVR12LOD [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
SVR12LOD is defined as HCV RNA laboratory value <LOD, 12 weeks after the end of treatment. The assay used in this study as a repoated LOD of 10 IU/ml.
Overall safety profile [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
The evaluation the overall safety profile will be measured by proportion of patients that discontinue study drug or require dose reduction or dose interruption due to treatment-emergent AEs.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Alisporivir With pegIFN/RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

Official Title ^ICMJE

A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1

Brief Summary

The purpose of this study is to evaluate the overall efficacy, and safety profile, of triple combination therapy of DEB025/pegIFN/RBV in chronic hepatitis C patients who failed prior treatment with PI.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C

Intervention ^ICMJE

Drug: Alisporivir

Patients will take two DEB025 200mg capsules twice per day along with a body weight managed dosage of RBV twice per day with an injection of peg/IFN once per week.

Study Arm (s)

Experimental: Alisporivir with peg-IFNα2a/RBV

PI failure patients with HCV GT1 will be enrolled into the study receiving DEB 025 (alsiporivir) 2 capsules (400 mg) BID, PegIFNα2a, 180 μg s.c. once weekly, and ribavirin, 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg) orally in two divided doses for 48 weeks

Intervention: Drug: Alisporivir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

HCV GT1 patients with previous PI treatment failure.
Timing of the PI treatment. the minimum time from the last dose of previous PI treatment to the first dose of study medication is three months.
Diagnosed Chronic hepatitis C virus infection
Infection with HCV genotype 1

Exclusion criteria:

Use of other investigational drugs at the time of enrollment,
History of hypersensitivity to any pegIFN or RBV.
Any null non-responders to prior pegIFN/RBV treatment,

Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01500772

Other Study ID Numbers ^ICMJE

CDEB025A2306, 2011-004653-31

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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