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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
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
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
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United States of America
State/province [7] 0 0
Minnesota
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United States of America
State/province [8] 0 0
Nebraska
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United States of America
State/province [9] 0 0
North Carolina
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United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
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Brazil
State/province [13] 0 0
Campinas
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre
Country [15] 0 0
Brazil
State/province [15] 0 0
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
State/province [19] 0 0
Beijing
Country [20] 0 0
China
State/province [20] 0 0
Chengdu
Country [21] 0 0
China
State/province [21] 0 0
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
Country [25] 0 0
China
State/province [25] 0 0
Shanghai
Country [26] 0 0
France
State/province [26] 0 0
Clichy
Country [27] 0 0
France
State/province [27] 0 0
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
Country [31] 0 0
Germany
State/province [31] 0 0
Hannover
Country [32] 0 0
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
Country [38] 0 0
New Zealand
State/province [38] 0 0
Otahuhu
Country [39] 0 0
Poland
State/province [39] 0 0
Bialystok
Country [40] 0 0
Poland
State/province [40] 0 0
Bydgoszcz
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
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Puerto Rico
State/province [42] 0 0
Santurce
Country [43] 0 0
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/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
Other publications