Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
2 other identifiers
interventional
340
14 countries
73
Brief Summary
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2010
73 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
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 6, 2010
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
August 30, 2016
CompletedAugust 30, 2016
July 1, 2016
1.6 years
October 5, 2010
July 20, 2016
July 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.
after 4 weeks of treatment
Secondary Outcomes (17)
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
after 4 weeks of treatment
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
after 12 weeks of treatment
- +12 more secondary outcomes
Study Arms (5)
ALV 1000 mg
EXPERIMENTALAlisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
ALV 600 mg+RBV
EXPERIMENTALAlisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
ALV 800 mg+RBV
EXPERIMENTALAlisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg+PEG
EXPERIMENTALAlisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
PEG+RBV
ACTIVE COMPARATORPeginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Interventions
ALV 200 mg soft gel capsules administered orally
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Eligibility Criteria
You may qualify if:
- Chronic hepatitis C viral infection
- Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
- HCV genotype 2 or 3
- No previous treatment for hepatitis C infection
You may not qualify if:
- Evidence of cirrhosis at the time of screening
- Evidence of hepatocellular carcinoma at the time of screening
- Any other cause of relevant liver disease other than HCV
- Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Scripps Clinic
La Jolla, California, 92037, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92101, United States
Research and Education Inc.
San Diego, California, 92105, United States
Island View Gastroenterology Associates
Ventura, California, 93003, United States
Hawai Medical Center East LLC
Honolulu, Hawaii, 96817, United States
Cotton O'Neil Clinical Research
Topeka, Kansas, 66606, United States
The Office of Dr. Claudia Martorell
Springfield, Massachusetts, 01107, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
The North Texas Research Institute
Arlington, Texas, 76012, United States
Liver Associates of Texas
Houston, Texas, 77030, United States
Liver Specialist of Texas
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Novartis Investigative Site
Kingswood, New South Wales, 2747, Australia
Novartis Investigative Site
Kogarah, New South Wales, 2217, Australia
Novartis Investigative Site
Westmead, New South Wales, 2145, Australia
Novartis Investigative Center
Greenslopes, Queensland, 4120, Australia
Novartis Investigative Site
Clayton, Victoria, 3168, Australia
Novartis Investigative Site
Fitzroy, Victoria, 3065, Australia
Novartis Investigative Site
Brussels, 1070, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1H2, Canada
Novartis Investigative Site
Toronto, Ontario, M4V 1P7, Canada
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Clichy, 92118, France
Novartis Investigative Site
Créteil, 94000, France
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Marseille, 13008, France
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Paris, 75006, France
Novartis Investigative Site
Berlin, 10969, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79095, Germany
Novartis Investigative Site
Hanover, 30625, Germany
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Leipzig, 04103, Germany
Novartis Investigative Site
Trivandrum, Kerala, 695607, India
Novartis Investigative Site
Mumbai, Maharashtra, 400036, India
Novartis Investigative Site
Ludhiana, Punjab, 141001, India
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Lucknow, Uttar Pradesh, 226014, India
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Guwahati, 781006, India
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Haryāna, 122001, India
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Hyderabad - Andhra Pradesh, 500012, India
Novartis Investigative Site
Mumbai, 400020, India
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New Delhi, 110070, India
Novartis Investigative Site
Bologna, 40138, Italy
Novartis Investigative Site
Brescia, 25123, Italy
Novartis Investigative Site
Pavia, 27100, Italy
Novartis Inestigative Site
Roma, 00133, Italy
Novartis Investigative Site
Torino, 10126, Italy
Novartis Investigative Site
Bialystok, 15-540, Poland
Novartis Investigative Site
Lódz, 91-347, Poland
Novartis Investigative Site
Warsaw, 01 - 201, Poland
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
Novartis Korea Ltd.
Seoul, Seoul, 120-752, South Korea
Novartis Inestigative Center
Pusan, 602-739, South Korea
Novartis Investigative Site
Pusan, 614-735, South Korea
Novartis Investigative Site
Seoul, 738-736, South Korea
Novartis Investigative Site
Douliu, Taiwan
Novartis Investigative Site
Kaohsiung City, 807, Taiwan
Novartis Investigative Site
Niaosong Township, 83301, Taiwan
Novartis Investigative Site
Taichung, 40447, Taiwan
Novartis Investigative Site
Taipei, 10002, Taiwan
Novartis Investigative Site
Taipei, ROC112, Taiwan
Novartis Investigative Site
Bangkok, 10700, Thailand
Novartis Investigative Site
Chiang Mai, 50200, Thailand
Novartis Investigative Site
Songkhla, 90110, Thailand
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Glasgow - Scotland, G12 OYN, United Kingdom
Novartis Investigative Site
London, E1 1BB, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
Novartis Investigative Site
London, SW17 0QT, United Kingdom
Novartis Investigative Site
London, W2 1NY, United Kingdom
Novartis Investigative Site
Plymouth, PL6 8DH, United Kingdom
Related Publications (1)
Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.
PMID: 26118427RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Clinical Research & Development
- Organization
- Debiopharm International S.A.
Study Officials
- STUDY DIRECTOR
Novartis Pharmceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 6, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 30, 2016
Results First Posted
August 30, 2016
Record last verified: 2016-07