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

This study has been completed.
Sponsor:
Collaborator:
Major Science and Technology Special Project of China Eleventh Five-year
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01086085
First received: March 11, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg posit ive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. A fter 24 weeks of treatment, rapid responders will receive another 24 weeks of tr eatment. After 24 weeks of treatment, slow responders will be randomized to anot her 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.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: Adefovir
Drug: peginterferon alfa-2a [PEGASYS]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction) [ Time Frame: Weeks 72, 96, 120 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml [ Time Frame: Weeks 24, 48, 72, 96, 120 ] [ Designated as safety issue: No ]
  • Safety: Adverse Events [ Time Frame: From baseline to Week 120 ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: April 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: peginterferon alfa-2a [PEGASYS]
Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Experimental: B Drug: peginterferon alfa-2a [PEGASYS]
Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Experimental: C Drug: peginterferon alfa-2a [PEGASYS]
Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks
Experimental: D Drug: Adefovir
Adefovir 10 mg po once daily for 36 weeks
Drug: peginterferon alfa-2a [PEGASYS]
Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086085

Locations
China
Beijing, China, 100034
Beijing, China, 100044
Beijing, China, 100011
Beijing, China, 100050
Changchun, China, 130021
Guangzhou, China, 510515
Shanghai, China, 200025
Shanghai, China, 200433
Shanghai, China, 200040
Wuhan, China, 430030
Xi'an, China, 710038
Sponsors and Collaborators
Hoffmann-La Roche
Major Science and Technology Special Project of China Eleventh Five-year
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01086085     History of Changes
Other Study ID Numbers: ML22266
Study First Received: March 11, 2010
Last Updated: August 4, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014