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NCT Number: NCT01086085

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adefovir

Drug

Adefovir 10 mg po once daily for 36 weeks

peginterferon alfa-2a [Pegasys]

Drug

Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

Primary outcomes

  1. Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)

    Time frame: Weeks 72, 96, 120

Secondary outcomes

  1. Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml

    Time frame: Weeks 24, 48, 72, 96, 120

  2. Safety: Adverse Events

    Time frame: From baseline to Week 120

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Major Science and Technology Special Project of China Eleventh Five-year

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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