A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels
NCT ID: NCT02726022
Last Updated: 2016-08-15
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
114 participants
OBSERVATIONAL
2007-02-28
2011-07-31
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.
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy
NCT01416610
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.
NCT00475072
PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)
NCT01070550
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
NCT00087568
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
NCT00545233
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.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.
Peginterferon alfa-2a
As per treating physician discretion and according to summary of product characteristics.
Ribavirin
As per treating physician discretion and according to summary of product characteristics.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peginterferon alfa-2a
As per treating physician discretion and according to summary of product characteristics.
Ribavirin
As per treating physician discretion and according to summary of product characteristics.
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 ribonucleic acid (RNA) positive
* CHC with normal transaminases
* Compensated liver disease
* Non-pregnant and willing to use two contraceptive methods (if fertile)
* At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin
Exclusion Criteria
* Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
* History of seizures or depression
* History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
* Uncontrolled thyroid disease
* Severe retinopathy
* Leukopenia or thrombocytopenia
* Bleeding esophageal varices or other evidence of hepatic decompensation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
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.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aigaleo - Attiki, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Piraeus, , Greece
Piraeus, , Greece
Thessaloniki, , Greece
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.
ML20151
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.