A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
NCT ID: NCT00614471
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
PHASE4
219 participants
INTERVENTIONAL
2007-08-31
2009-10-31
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.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks
2
Entecavir
0.5mg po daily from week 13 to week 36
peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks
3
Entecavir
0.5mg po daily for 24 weeks
peginterferon alfa-2a [Pegasys]
180 micrograms sc/week from week 21 to week 68
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Entecavir
0.5mg po daily for 24 weeks
Entecavir
0.5mg po daily from week 13 to week 36
peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks
peginterferon alfa-2a [Pegasys]
180 micrograms sc/week from week 21 to week 68
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
* absence of cirrhosis confirmed by liver biopsy in previous 12 months.
Exclusion Criteria
* antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
* co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
* history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.
18 Years
65 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.
Beijing, , China
Hangzhou, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Xi'an, , China
Zhengzhou, , China
Hong Kong, , Hong Kong
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.
Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML20742
Identifier Type: -
Identifier Source: org_study_id