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

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ClinicalTrials.gov Identifier: NCT00048945
Recruitment Status : Completed
First Posted : November 14, 2002
Last Update Posted : February 17, 2017
Sponsor:
Information provided by:
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: PEGASYS Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Primary Purpose: Treatment
Actual Study Start Date : January 2002
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


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Sponsors and Collaborators
Hoffmann-La Roche

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ClinicalTrials.gov Identifier: NCT00048945     History of Changes
Other Study ID Numbers: WV16240
First Posted: November 14, 2002    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents