Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
NCT ID: NCT01318694
Last Updated: 2016-09-30
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
PHASE3
1081 participants
INTERVENTIONAL
2011-03-31
2013-08-31
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.
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 Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
NCT01215643
Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C
NCT01500772
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
NCT01970904
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
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm A
Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):
* Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks
* Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Treatment Arm B
Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Treatment Arm C
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Treatment Arm D
ALV Placebo with PEG and RBV for 48 weeks
Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Ribavirin
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
ALV Placebo
ALV placebo soft gel capsules administered orally
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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
ALV Placebo
ALV placebo soft gel capsules administered orally
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
* HCV genotype 1
* No previous treatment for hepatitis C infection
* Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
* Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months
Exclusion Criteria
* Co-infection with Hepatitis B or HIV
* Any other cause of relevant liver disease other than HCV
* Presence or history of hepatic decompensation
* Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (\> ULN) in past 6 months
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 Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Oakland, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Ventura, California, United States
Novartis Investigative Site
Bradenton, Florida, United States
Novartis Investigative Site
Maitland, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Springfield, Illinois, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
Shreveport, Louisiana, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Newark, New Jersey, United States
Novartis Investigative Site
Brooklyn, 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
Charlotte, North Carolina, United States
Novartis Investigative Site
Fayetteville, North Carolina, United States
Novartis Investigative Site
Arlington, Texas, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Fairfax, Virginia, United States
Novartis Investigative Site
Newport News, Virginia, United States
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
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 Site
Greenslopes, Queensland, Australia
Novartis Investigative Site
Fitzroy, Victoria, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Downsview, Ontario, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Clichy, , France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Freiburg im Breisgau, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Kiel, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Hong Kong, Hong Kong, Hong Kong
Novartis Investigative Site
Békéscsaba, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Kaposvár, , Hungary
Novartis Investigative Site
Pécs, , Hungary
Novartis Investigative Site
Székesfehérvár, , Hungary
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Palermo, PA, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Bydgoszcz, , Poland
Novartis Investigative Site
Chorzów, , Poland
Novartis Investigative Site
Kielce, , Poland
Novartis Investigative Site
Lódz, , Poland
Novartis Investigative Site
San Juan, , Puerto Rico
Novartis Investigative Site
Bucharest, District 1, Romania
Novartis Investigative Site
Bucharest, District 3, Romania
Novartis Investigative Site
Iași, Iaşi, Romania
Novartis Investigative Site
Iași, Jud. Iasi, Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Cluj-Napoca, , Romania
Novartis Investigative Site
Craiova, , Romania
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Busan, Busan, South Korea
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Kyunggi, Kyeonggi, South Korea
Novartis Investigative Site
Busan, , South Korea
Novartis Investigative Site
Incheon, , South Korea
Novartis Investigative Site
Pusan, , South Korea
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Majadahonda, Madrid, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Chiayi City, Taiwan, Taiwan
Novartis Investigative Site
Niaosong Township, Taiwan, Taiwan
Novartis Investigative Site
Taichung, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Douliu, , Taiwan
Novartis Investigative Site
Kaohsiung City, , Taiwan
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Novartis Investigative Site
Khon Kaen, , Thailand
Novartis Investigative Site
Songkhla, , Thailand
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, , United Kingdom
Novartis Investigative Site
Nottingham, , United Kingdom
Novartis Investigative Site
Hanoi, , Vietnam
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-022867-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDEB025A2301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.