A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials
NCT ID: NCT01853254
Last Updated: 2013-09-04
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
272 participants
INTERVENTIONAL
2003-09-30
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Peginterferon alfa-2a monotherapy or combined with ribavirin
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
Peginterferon alfa-2a
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
Ribavirin
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peginterferon alfa-2a
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
Ribavirin
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
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
* Chronic hepatitis C.
* Compensated liver disease (Child-Pugh Class A).
* Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
* Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
* Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
* For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
* Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Exclusion Criteria
* Male partners of women who are pregnant.
* Patients with hemoglobinopathies.
* Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
* Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
* Liver disease other than chronic hepatitis C, including hepatic carcinoma.
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_CHAIR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
La Jolla, California, United States
Long Beach, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Framingham, Massachusetts, United States
Worcester, Massachusetts, United States
Plymouth, Minnesota, United States
Newark, New Jersey, United States
Vineland, New Jersey, United States
Binghamton, New York, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Durham, North Carolina, United States
Statesville, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Adelaide, , Australia
Herston, , Australia
Ribeirão Preto, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Vandœuvre-lès-Nancy, , France
Thessaloniki, , Greece
Bergamo, , Italy
Napoli, , Italy
Warsaw, , Poland
Ponce, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Santurce, , Puerto Rico
Barcelona, , Spain
Taoyuan District, , Taiwan
Plymouth, , United Kingdom
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.
NV17590
Identifier Type: -
Identifier Source: org_study_id