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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   

ChemIDplus related topics:   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  Show 74 Study Locations

Sponsors and Collaborators
Hoffmann-La Roche
  More Information


Study ID Numbers:   WV16240
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 October 07, 2008




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