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CompletedNCT00048945Updated Feb 17, 2017

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

A Phase 3 interventional study of PEGASYS in Chronic Hepatitis B, sponsored by Hoffmann-La Roche. Completed at 74 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2002, registered Nov 2002).
Phase
Phase 3
Study type
Interventional
Enrollment
820
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 820 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of hepatitis B
  • Not pregnant

Exclusion criteria

Exclusion Criteria:

  • Treatment for hepatitis B in past 6 months
  • Other hepatitis infections
  • Severe liver disease
  • Pregnancy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Enrollment
820 participants (actual)

Interventions

  • DrugPEGASYS
06

Study locations

74 sites
  • Scottsdale, Arizona 85259, United States
  • Downey, California 90242, United States
  • Los Angeles, California 90048, United States
  • Pasadena, California 91105, United States
  • San Francisco, California 94115, United States
  • Atlanta, Georgia 30308, United States
  • Honolulu, Hawaii 96817, United States
  • Boston, Massachusetts 02111, United States
  • Ann Arbor, Michigan 48109, United States
  • Minneapolis, Minnesota 55404-4565, United States
  • Lincoln, Nebraska 68501, United States
  • Chapel Hill, North Carolina 27599-7080, United States
  • Cedar Creek, Texas 78612, United States
  • Salt Lake City, Utah 84121, United States
  • Seattle, Washington 98195, United States
  • Concord, 2139, Australia
  • Herston, 4029, Australia
  • Campinas, 13081-970, Brazil
  • Porto Alegre, 90035-003, Brazil
  • Salvador, 40150-130, Brazil
  • Sao Paulo, 01246-900, Brazil
  • Calgary, Alberta T2N 4N1, Canada
  • Toronto, Ontario M5G 1L7, Canada
  • Toronto, Ontario M5G 1X5, Canada
  • Beijing, 100011, China
  • Beijing, 100034, China
  • Beijing, 100039, China
  • Beijing, 100050, China
  • Beijing, 100054, China
  • Chengdu, 610041, China
  • Chongqing, 400010, China
  • Guangzhou, 510515, China
  • Guangzhou, 510630, China
  • Hangzhou, 310003, China
  • Hong Kong, China
  • Shanghai, 200025, China
  • Shanghai, 200040, China
  • Shanghai, 200433, China
  • Clichy, 92110, France
  • Lyon, 69288, France
  • Berlin, 13353, Germany
  • Bochum, 44791, Germany
  • Duesseldorf, 40225, Germany
  • Hannover, 30623, Germany
  • Koeln, 50931, Germany
  • Muenchen, 81377, Germany
  • Haifa, 31096, Israel
  • Petach Tikva, 49100, Israel
  • Tel Aviv, 64239, Israel
  • Seoul, 120-752, Korea, Republic of
  • Seoul, 135-170, Korea, Republic of
  • Seoul, 138-736, Korea, Republic of
  • Seoul, 150-713, Korea, Republic of
  • Otahuhu, New Zealand
  • Bialystok, 15-540, Poland
  • Bydgoszcz, 85-030, Poland
  • Warszawa, 01-201, Poland
  • Santurce, 00909, Puerto Rico
  • Singapore, 159402, Singapore
  • Singapore, 169608, Singapore
  • Singapore, 228510, Singapore
  • Basel, 4031, Switzerland
  • Kaohsiung, Taiwan
  • Kwei Shan, Taiwan
  • Tainan, Taiwan
  • Taipei, 100, Taiwan
  • Taipei, 114, Taiwan
  • Taipei, Taiwan
  • Bangkok, 10330, Thailand
  • Bangkok, 10400, Thailand
  • Bangkok, 10700, Thailand
  • Chiang Mai, 50202, Thailand
  • Songkla, 90112, Thailand
  • Nottingham, NG2 3HF, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00048945
Lead sponsor
Hoffmann-La Roche
First posted
Nov 14, 2002
Start date
Jan 2002
Primary completion
Oct 2004
Completion
Oct 2004
Last update
Feb 17, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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