Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B

This study has been completed.

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048945

Purpose

The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: PEGASYS	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Peginterferon Alfa-2a Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of hepatitis B
Not pregnant

Exclusion Criteria:

Treatment for hepatitis B in past 6 months
Other hepatitis infections
Severe liver disease
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048945

Show 74 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Study ID Numbers:	WV16240
Study First Received:	November 12, 2002
Last Updated:	August 11, 2005
ClinicalTrials.gov Identifier:	NCT00048945
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis B, Chronic
Hepatitis B
Peginterferon alfa-2a
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009