Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
NCT ID: NCT01754974
Last Updated: 2015-01-28
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
40 participants
INTERVENTIONAL
2013-03-31
2014-09-30
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 Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
NCT01447394
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
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
NCT01598090
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
NCT01718158
Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
NCT01797848
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Peginterferon Lambda-1a + Ribavirin
Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
Peginterferon Lambda-1a
Ribavirin
Peginterferon alfa-2a + Ribavirin
Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
Ribavirin
Peginterferon alfa-2a
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peginterferon Lambda-1a
Ribavirin
Peginterferon alfa-2a
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 RNA ≥100,000 IU/mL at screening
* Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
* Naïve to prior anti-HCV therapy
Exclusion Criteria
* Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody at screening
* Evidence of liver disease other than HCV
* Active substance abuse
* Use of hematologic growth factors within 90 days prior to study randomization
* Evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria
18 Years
70 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.
Local Institution
Hradec Králové, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Ústí nad Labem, , Czechia
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Distrito Federal, Mexico City, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
México, State of Mexico, Mexico
Local Institution
Chungcheongnam-do, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Gangwon-do, , South Korea
Local Institution
Gyeonggi-do, , South Korea
Local Institution
Gyeonggi-do, , South Korea
Local Institution
Gyeongsangnam-do, , South Korea
Local Institution
Incheon, , South Korea
Local Institution
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
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.
2012-003508-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-033
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.