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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00048945




Registration number
NCT00048945
Ethics application status
Date submitted
12/11/2002
Date registered
14/11/2002
Date last updated
17/02/2017

Titles & IDs
Public title
Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B
Scientific title
Secondary ID [1] 0 0
WV16240
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEGASYS

Treatment: Drugs: PEGASYS
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Clinical diagnosis of hepatitis B

- Not pregnant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment for hepatitis B in past 6 months

- Other hepatitis infections

- Severe liver disease

- Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2004
Sample size
Target
Accrual to date
Final
820
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Herston
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
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Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Nebraska
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United States of America
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North Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Washington
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Brazil
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Campinas
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Brazil
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Porto Alegre
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Brazil
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Salvador
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
China
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Beijing
Country [20] 0 0
China
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Chengdu
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China
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Chongqing
Country [22] 0 0
China
State/province [22] 0 0
Guangzhou
Country [23] 0 0
China
State/province [23] 0 0
Hangzhou
Country [24] 0 0
China
State/province [24] 0 0
Hong Kong
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China
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Shanghai
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France
State/province [26] 0 0
Clichy
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France
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Lyon
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Bochum
Country [30] 0 0
Germany
State/province [30] 0 0
Duesseldorf
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Germany
State/province [31] 0 0
Hannover
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Germany
State/province [32] 0 0
Koeln
Country [33] 0 0
Germany
State/province [33] 0 0
Muenchen
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Petach Tikva
Country [36] 0 0
Israel
State/province [36] 0 0
Tel Aviv
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
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New Zealand
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Otahuhu
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Warszawa
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Puerto Rico
State/province [42] 0 0
Santurce
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Singapore
State/province [43] 0 0
Singapore
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Switzerland
State/province [44] 0 0
Basel
Country [45] 0 0
Taiwan
State/province [45] 0 0
Kaohsiung
Country [46] 0 0
Taiwan
State/province [46] 0 0
Kwei Shan
Country [47] 0 0
Taiwan
State/province [47] 0 0
Tainan
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Thailand
State/province [49] 0 0
Bangkok
Country [50] 0 0
Thailand
State/province [50] 0 0
Chiang Mai
Country [51] 0 0
Thailand
State/province [51] 0 0
Songkla
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00048945
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00048945