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

February 16, 2017 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

820

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia, 2139
      • Herston, Australia, 4029
  • Brazil
      • Campinas, Brazil, 13081-970
      • Porto Alegre, Brazil, 90035-003
      • Salvador, Brazil, 40150-130
      • Sao Paulo, Brazil, 01246-900
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • Ontario
      • Toronto, Ontario, Canada, M5G 1L7
      • Toronto, Ontario, Canada, M5G 1X5
  • China
      • Beijing, China, 100050
      • Beijing, China, 100011
      • Beijing, China, 100034
      • Beijing, China, 100039
      • Beijing, China, 100054
      • Chengdu, China, 610041
      • Chongqing, China, 400010
      • Guangzhou, China, 510630
      • Guangzhou, China, 510515
      • Hangzhou, China, 310003
      • Hong Kong, China
      • Shanghai, China, 200025
      • Shanghai, China, 200040
      • Shanghai, China, 200433
  • France
      • Clichy, France, 92110
      • Lyon, France, 69288
  • Germany
      • Berlin, Germany, 13353
      • Bochum, Germany, 44791
      • Duesseldorf, Germany, 40225
      • Hannover, Germany, 30623
      • Koeln, Germany, 50931
      • Muenchen, Germany, 81377
  • Israel
      • Haifa, Israel, 31096
      • Petach Tikva, Israel, 49100
      • Tel Aviv, Israel, 64239
  • Korea, Republic of
      • Seoul, Korea, Republic of, 150-713
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-170
  • New Zealand
      • Otahuhu, New Zealand
  • Poland
      • Bialystok, Poland, 15-540
      • Bydgoszcz, Poland, 85-030
      • Warszawa, Poland, 01-201
  • Puerto Rico
      • Santurce, Puerto Rico, 00909
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 228510
      • Singapore, Singapore, 159402
  • Switzerland
      • Basel, Switzerland, 4031
  • Taiwan
      • Kaohsiung, Taiwan
      • Kwei Shan, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Taipei, Taiwan, 100
      • Taipei, Taiwan, 114
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50202
      • Songkla, Thailand, 90112
  • United Kingdom
      • Nottingham, United Kingdom, NG2 3HF
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • Downey, California, United States, 90242
      • Los Angeles, California, United States, 90048
      • Pasadena, California, United States, 91105
      • San Francisco, California, United States, 94115
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404-4565
    • Nebraska
      • Lincoln, Nebraska, United States, 68501
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7080
    • Texas
      • Cedar Creek, Texas, United States, 78612
    • Utah
      • Salt Lake City, Utah, United States, 84121
    • Washington
      • Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2002

Primary Completion (ACTUAL)

October 1, 2004

Study Completion (ACTUAL)

October 1, 2004

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

November 13, 2002

First Posted (ESTIMATE)

November 14, 2002

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WV16240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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