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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01500772
• Other study ID #: CDEB025A2306
• Secondary ID: 2011-004653-31
• Status: Terminated
• Phase: Phase 3
• First received: December 23, 2011
• Last updated: April 1, 2016
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2016
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. HCV GT1 patients with previous PI treatment failure.

2. 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.

3. Diagnosed Chronic hepatitis C virus infection

4. Infection with HCV genotype 1

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment,

2. History of hypersensitivity to any pegIFN or RBV.

3. Any null non-responders to prior pegIFN/RBV treatment,

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Vancouver	British Columbia
France	Novartis Investigative Site	Clichy
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Paris
Germany	Novartis Investigational Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigational Site	Frieburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigational Site	Koln
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigational Site	Mainz
Germany	Novartis Investigative Site	Mainz
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Torino	TO
Puerto Rico	Novartis Investigative Site	San Juan
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Majadanonda	Madrid
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Alexandria	Virginia
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Bakersfield	California
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigational site	Bradenton	Florida
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Brockton	Massachusetts
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	Palo Alto	California
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Providence	Rhode Island
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Ventura	California
United States	Novartis Investigative Site	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	SVR12 is defined as HCV RNA laboratory value	12 weeks after the end of treatment	No
Secondary	SVR24	SVR24 is defined as HCV RNA laboratory value	24 weeks after the end of treatment	No
Secondary	SVR12LOD	SVR12LOD is defined as HCV RNA laboratory value	12 weeks after the end of treatment	No
Secondary	Overall safety profile	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.	48 weeks	Yes