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

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PEGASYS
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2002
Last Updated
February 16, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00048945
Brief Title
Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2002 (Actual)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
820 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PEGASYS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404-4565
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68501
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
City
Cedar Creek
State/Province
Texas
ZIP/Postal Code
78612
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
City
Concord
ZIP/Postal Code
2139
Country
Australia
City
Herston
ZIP/Postal Code
4029
Country
Australia
City
Campinas
ZIP/Postal Code
13081-970
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
City
Salvador
ZIP/Postal Code
40150-130
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01246-900
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Beijing
ZIP/Postal Code
100011
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100039
Country
China
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
100054
Country
China
City
Chengdu
ZIP/Postal Code
610041
Country
China
City
Chongqing
ZIP/Postal Code
400010
Country
China
City
Guangzhou
ZIP/Postal Code
510515
Country
China
City
Guangzhou
ZIP/Postal Code
510630
Country
China
City
Hangzhou
ZIP/Postal Code
310003
Country
China
City
Hong Kong
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Clichy
ZIP/Postal Code
92110
Country
France
City
Lyon
ZIP/Postal Code
69288
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
City
Hannover
ZIP/Postal Code
30623
Country
Germany
City
Koeln
ZIP/Postal Code
50931
Country
Germany
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-170
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
City
Otahuhu
Country
New Zealand
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
City
Singapore
ZIP/Postal Code
159402
Country
Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Kaohsiung
Country
Taiwan
City
Kwei Shan
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
City
Taipei
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50202
Country
Thailand
City
Songkla
ZIP/Postal Code
90112
Country
Thailand
City
Nottingham
ZIP/Postal Code
NG2 3HF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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