Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy
NCT ID: NCT01718158
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
444 participants
INTERVENTIONAL
2013-01-31
2014-10-31
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.
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
NCT01616524
Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
NCT01754974
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
NCT01598090
Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
NCT01797848
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
NCT01447394
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.
Peginterferon Lambda-1a + Ribavirin + Daclatasvir
Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks
Ribavirin 200 mg tablets \[1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects \< 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food\] by mouth, twice daily, for 24 weeks
Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks
Peginterferon Lambda-1a
Ribavirin
Daclatasvir
Peginterferon Alfa-2a + Ribavirin + Telaprevir
Peginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response
Ribavirin 200 mg tablets \[1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects \< 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food\] by mouth, twice daily, for 24 to 48 weeks depending on response
Telaprevir 375 mg tablets \[2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks
Peginterferon Alfa-2a
Ribavirin
Telaprevir
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peginterferon Lambda-1a
Peginterferon Alfa-2a
Ribavirin
Daclatasvir
Telaprevir
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
* Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
* HCV RNA viral load ≥100,000 IU/mL at screening
* Patients with compensated cirrhosis are permitted
Exclusion Criteria
* Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
* Evidence of chronic liver disease caused by diseases other than chronic HCV infection
* Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
* Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
* Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
* Laboratory values:
1. Hemoglobin \<12.0 g/dL (males) or \<11.0 g/dL (females)
2. Platelets \<90,000/mm3
3. Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
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.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Va Long Beach Healthcare System
Long Beach, California, United States
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, United States
Weill Cornell Medical College
New York, New York, United States
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Texas Clinical Research Institute, Llc
Arlington, Texas, United States
Medvamc
Houston, Texas, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Mar del Plata, Buenos Aires, Argentina
Local Institution
Prov de Santa Fe, Santa Fe Province, Argentina
Local Institution
Clichy, , France
Local Institution
Grenoble, , France
Local Institution
Villejuif, , France
Local Institution
Berlin, , Germany
Local Institution
Essen, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Mannheim, , Germany
Local Institution
München, , Germany
Local Institution
Haifa, , Israel
Local Institution
Tel Aviv, , Israel
Local Institution
Tel Litwinsky, , Israel
Local Institution
Zafed, , Israel
Local Institution
Foggia, , Italy
Local Institution
Messina, , Italy
Local Institution
Modena, , Italy
Local Institution
Pavia, , Italy
Local Institution
Pisa, , Italy
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Kitakyushu, Fukuoka, Japan
Local Institution
Kitakyushu-shi, Fukuoka, Japan
Local Institution
Gifu, Gifu, Japan
Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kobe, Hyōgo, Japan
Local Institution
Higashiibaraki-gun, Ibaraki, Japan
Local Institution
Kawasaki-shi, Kanagawa, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution
Kumamoto, Kumamoto, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Saga, Saga-ken, Japan
Local Institution
Minato-ku, Tokyo, Japan
Local Institution
Musashino-shi, Tokyo, Japan
Local Institution
Sumida-ku, Tokyo, Japan
Local Institution
Tanabe-shi, Wakayama, Japan
Local Institution
Bialystok, , Poland
Local Institution
Lodz, , Poland
Local Institution
Mysłowice, , Poland
Local Institution
Wroclaw, , Poland
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Stavropol, , Russia
Local Institution
Busan, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Santander, , Spain
Local Institution
Zaragoza, , Spain
Local Institution
Kaohsiung, Taiwan, Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Tainan City, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan District, , Taiwan
Local Institution
London, Greater London, 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.
Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S. Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b. J Interferon Cytokine Res. 2016 Nov;36(11):635-643. doi: 10.1089/jir.2015.0173. Epub 2016 Jun 21.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-005409-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.