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A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Adefovir (Drug); peginterferon alfa-2a [PEGASYS] (Drug); peginterferon alfa-2a [PEGASYS] (Drug); peginterferon alfa-2a [PEGASYS] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.

Clinical Details

Official title: A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)

Secondary outcome:

Proportion of patients achieving HBeAG seroconversion and HBV DNA Safety: Adverse Events


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Adult patients >/=18 years of age

- HBeAg positive chronic hepatitis B

- Compensated liver disease

Exclusion Criteria:

- Patients who had previously received treatment of drugs with activity against HBV

within 6 months prior to study start

- Antiviral, anti-neoplastic or immunomodulatory treatment

- Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV

- Evidence of decompensated liver disease

- Chronic liver disease other than viral hepatitis

Locations and Contacts

Beijing 100044, China

Beijing 100034, China

Beijing 100011, China

Beijing 100050, China

Changchun 130021, China

Guangzhou 510515, China

Shanghai 200025, China

Shanghai 200040, China

Shanghai 200433, China

Wuhan 430030, China

Xi'an 710038, China

Additional Information

Starting date: April 2010
Last updated: August 17, 2015

Page last updated: August 23, 2015

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