Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C
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
2 other identifiers
interventional
6
8 countries
60
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
June 27, 2016
CompletedAugust 1, 2016
June 1, 2016
2 months
December 23, 2011
May 19, 2016
June 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
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.
12 weeks posttreatment
Secondary Outcomes (3)
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
24 weeks posttreatment
Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
12 weeks posttreatment
Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
48 weeks
Study Arms (1)
Alisporivir
EXPERIMENTALALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Interventions
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Eligibility Criteria
You may qualify if:
- Patients with chronic HCV genotype 1 infection with previous PI treatment failure
- Three months minimum time from the last dose of previous PI treatment to the first dose of study medication
You may not qualify if:
- Use of other investigational drugs at the time of enrollment
- History of hypersensitivity to PEG or RBV
- Any null non-responders to prior PEG/RBV treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Novartis Investigative Site
Phoenix, Arizona, 85054, United States
Novartis Investigative Site
Bakersfield, California, 93301, United States
Novartis Investigative Site
Los Angeles, California, 90033, United States
Novartis Investigative Site
Palo Alto, California, 95128, United States
Novartis Investigative Site
Sacramento, California, 95817, United States
Novartis Investigative Site
San Diego, California, 92114, United States
Novartis Investigative Site
San Diego, California, 92128, United States
Novartis Investigative Site
Ventura, California, 93003, United States
Novartis Investigational site
Bradenton, Florida, 34209, United States
Novartis Investigative Site
Bradenton, Florida, 34209, United States
Novartis Investigative Site
Miami, Florida, 33136, United States
Novartis Investigative Site
Wellington, Florida, 33414, United States
Novartis Investigative Site
Chicago, Illinois, 60611, United States
Novartis Investigative Site
Baltimore, Maryland, 21229, United States
Novartis Investigative Site
Brockton, Massachusetts, 02302, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55404, United States
Novartis Investigative Site
St Louis, Missouri, 63110, United States
Novartis Investigative Site
New York, New York, 10021, United States
Novartis Investigative Site
New York, New York, 10029, United States
Novartis Investigative Site
New York, New York, 10032, United States
Novartis Investigative Site
Cincinnati, Ohio, 45267, United States
Novartis Investigative Site
Providence, Rhode Island, 02905, United States
Novartis Investigative Site
Arlington, Texas, 76012, United States
Novartis Investigative Site
Dallas, Texas, 75246, United States
Novartis Investigative Site
Alexandria, Virginia, 22306, United States
Novartis Investigative Site
Newport News, Virginia, 23602, United States
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1J4, Canada
Novartis Investigative Site
Vancouver, British Columbia, v6z 2k5, Canada
Novartis Investigative Site
Clichy, 92110, France
Novartis Investigative Site
Créteil, 94000, France
Novartis Investigative Site
Paris, 75006, France
Novartis Investigational Site
Berlin, 10969, Germany
Novartis Investigative Site
Berlin, 10969, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigational Site
Cologne, 50924, Germany
Novartis Investigative Site
Cologne, 50924, Germany
Novartis Investigative Site
Düsseldorf, 40225, Germany
Novartis Investigative Site
Düsseldorf, 40237, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
Freiburg im Breisgau, 79106, Germany
Novartis Investigational Site
Frieburg, 79106, Germany
Novartis Investigative Site
Hamburg, 20099, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Kiel, 24146, Germany
Novartis Investigational Site
Mainz, 55131, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Florence, FI, 50134, Italy
Novartis Investigative Site
Milan, MI, 20122, Italy
Novartis Investigative Site
Modena, MO, 41124, Italy
Novartis Investigative Site
Palermo, PA, 90127, Italy
Novartis Investigative Site
Padua, PD, 35128, Italy
Novartis Investigative Site
Roma, RM, 00161, Italy
Novartis Investigative Site
Torino, TO, 10126, Italy
Novartis Investigative Site
Bologna, 40138, Italy
Novartis Investigative Site
San Juan, 00909, Puerto Rico
Novartis Investigative Site
Barcelona, Barcelona, 08035, Spain
Novartis Investigative Site
Majadanonda, Madrid, 28222, Spain
Novartis Investigative Site
London, NW3 3QG, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to early termination of the study, none of the planned outcome measures could be evaluated.
Results Point of Contact
- Title
- Vice President, Clinical Research and Development
- Organization
- Debiopharm International S.A.
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2011
First Posted
December 28, 2011
Study Start
March 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 1, 2016
Results First Posted
June 27, 2016
Record last verified: 2016-06