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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00048945
First Posted: November 14, 2002
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hoffmann-La Roche
  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 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Enrollment: 820
Actual Study Start Date: January 2002
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048945


  Show 74 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

ClinicalTrials.gov Identifier: NCT00048945     History of Changes
Other Study ID Numbers: WV16240
First Submitted: November 12, 2002
First Posted: November 14, 2002
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents