NCT00048945

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
820

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2002

Typical duration for phase_3

Geographic Reach
17 countries

74 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

November 12, 2002

Last Update Submit

February 16, 2017

Conditions

Chronic Hepatitis B

Interventions

PEGASYSDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of hepatitis B
  • Not pregnant

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (74)

Unknown Facility

Scottsdale, Arizona, 85259, United States

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Downey, California, 90242, United States

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Los Angeles, California, 90048, United States

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Pasadena, California, 91105, United States

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San Francisco, California, 94115, United States

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Atlanta, Georgia, 30308, United States

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Honolulu, Hawaii, 96817, United States

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Boston, Massachusetts, 02111, United States

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Ann Arbor, Michigan, 48109, United States

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Minneapolis, Minnesota, 55404-4565, United States

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Lincoln, Nebraska, 68501, United States

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Chapel Hill, North Carolina, 27599-7080, United States

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Cedar Creek, Texas, 78612, United States

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Salt Lake City, Utah, 84121, United States

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Seattle, Washington, 98195, United States

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Concord, 2139, Australia

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Herston, 4029, Australia

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Campinas, 13081-970, Brazil

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Porto Alegre, 90035-003, Brazil

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Salvador, 40150-130, Brazil

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São Paulo, 01246-900, Brazil

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Calgary, Alberta, T2N 4N1, Canada

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Toronto, Ontario, M5G 1L7, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Beijing, 100011, China

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Beijing, 100034, China

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Beijing, 100039, China

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Beijing, 100050, China

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Beijing, 100054, China

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Chengdu, 610041, China

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Chongqing, 400010, China

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Guangzhou, 510515, China

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Guangzhou, 510630, China

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Hangzhou, 310003, China

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Hong Kong, China

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Shanghai, 200025, China

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Shanghai, 200040, China

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Shanghai, 200433, China

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Clichy, 92110, France

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Lyon, 69288, France

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Berlin, 13353, Germany

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Bochum, 44791, Germany

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Cologne, 50931, Germany

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Düsseldorf, 40225, Germany

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Hanover, 30623, Germany

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München, 81377, Germany

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Haifa, 31096, Israel

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Petah Tikva, 49100, Israel

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Tel Aviv, 64239, Israel

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Otahuhu, New Zealand

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Bialystok, 15-540, Poland

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Bydgoszcz, 85-030, Poland

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Warsaw, 01-201, Poland

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Santurce, 00909, Puerto Rico

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Singapore, 159402, Singapore

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Singapore, 169608, Singapore

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Singapore, 228510, Singapore

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Seoul, 120-752, South Korea

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Seoul, 135-170, South Korea

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Seoul, 138-736, South Korea

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Seoul, 150-713, South Korea

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Basel, 4031, Switzerland

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Kaohsiung City, Taiwan

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Kwei Shan, Taiwan

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Tainan, Taiwan

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Taipei, 100, Taiwan

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Taipei, 114, Taiwan

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Taipei, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50202, Thailand

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Songkhla, 90112, Thailand

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Nottingham, NG2 3HF, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2002

First Posted

November 14, 2002

Study Start

January 1, 2002

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

US(15)SG(3)TW(6)GB(1)DE(6)BR(4)NZ(1)KR(4)AU(2)FR(2)CH(1)CN(14)PR(1)PL(3)IL(3)CA(3)TH(5)