Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
NCT ID: NCT01215643
Last Updated: 2016-08-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
340 participants
INTERVENTIONAL
2010-10-31
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C
NCT01500772
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
NCT01183169
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
NCT01318694
A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
NCT00854802
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
NCT02094443
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ALV 1000 mg
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
Alisporivir
ALV 200 mg soft gel capsules administered orally
ALV 600 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
Alisporivir
ALV 200 mg soft gel capsules administered orally
Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
ALV 800 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
Alisporivir
ALV 200 mg soft gel capsules administered orally
Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
ALV 600 mg+PEG
Alisporivir (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.
Alisporivir
ALV 200 mg soft gel capsules administered orally
Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
PEG+RBV
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alisporivir
ALV 200 mg soft gel capsules administered orally
Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Debiopharm International SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scripps Clinic
La Jolla, California, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States
Research and Education Inc.
San Diego, California, United States
Island View Gastroenterology Associates
Ventura, California, United States
Hawai Medical Center East LLC
Honolulu, Hawaii, United States
Cotton O'Neil Clinical Research
Topeka, Kansas, United States
The Office of Dr. Claudia Martorell
Springfield, Massachusetts, United States
Saint Louis University
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Weill Cornell Medical Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
The North Texas Research Institute
Arlington, Texas, United States
Liver Associates of Texas
Houston, Texas, United States
Liver Specialist of Texas
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Novartis Investigative Site
Kingswood, New South Wales, Australia
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Center
Greenslopes, Queensland, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Fitzroy, Victoria, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Clichy, , France
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Freiburg im Breisgau, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Trivandrum, Kerala, India
Novartis Investigative Site
Mumbai, Maharashtra, India
Novartis Investigative Site
Ludhiana, Punjab, India
Novartis Investigative Site
Lucknow, Uttar Pradesh, India
Novartis Investigative Site
Guwahati, , India
Novartis Investigative Site
Haryāna, , India
Novartis Investigative Site
Hyderabad - Andhra Pradesh, , India
Novartis Investigative Site
Mumbai, , India
Novartis Investigative Site
New Delhi, , India
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Brescia, , Italy
Novartis Investigative Site
Pavia, , Italy
Novartis Inestigative Site
Roma, , Italy
Novartis Investigative Site
Torino, , Italy
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Lódz, , Poland
Novartis Investigative Site
Warsaw, , Poland
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Novartis Korea Ltd.
Seoul, Seoul, South Korea
Novartis Inestigative Center
Pusan, , South Korea
Novartis Investigative Site
Pusan, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Douliu, , Taiwan
Novartis Investigative Site
Kaohsiung City, , Taiwan
Novartis Investigative Site
Niaosong Township, , Taiwan
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Novartis Investigative Site
Songkhla, , Thailand
Novartis Investigative Site
Glasgow - Scotland, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Plymouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-020034-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDEB025A2211
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.