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

This study has been completed.

First Received on November 12, 2002. Last Updated on August 11, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

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

No publications provided

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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012