A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
NCT ID: NCT01749150
Last Updated: 2016-11-02
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
PHASE2
61 participants
INTERVENTIONAL
2013-04-30
2015-02-28
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.
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
with cirrhosis
danoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 24 weeks
without cirrhosis
danoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 12 weeks
ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
danoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
danoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 12 weeks
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 12 weeks
ribavirin [Copegus]
1000-1200 mg orally daily in divided doses, 24 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of chronic genotype 1 hepatitis C infection
* Treatment-naïve
Exclusion Criteria
* Presence or history of non-hepatitis C chronic liver disease
* Positive for hepatitis B or HIV infection
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.
Busan, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Chiayi County, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Yunlin County, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
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.
YV28218
Identifier Type: -
Identifier Source: org_study_id