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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00496002




Registration number
NCT00496002
Ethics application status
Date submitted
2/07/2007
Date registered
4/07/2007
Date last updated
27/04/2009

Titles & IDs
Public title
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
Scientific title
A Multi-Center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared With Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
Secondary ID [1] 0 0
CI-PSI-5268-06-305
Universal Trial Number (UTN)
Trial acronym
QUASH 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis 0 0
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
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg positive hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
* Subjects with historical biopsies used for entry will have chronic hepatic inflammatory injury at screening (Knodell HAI score = 4 and modified Ishak fibrosis score = 5). If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline.
* For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of = 50 mL/min.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded.
* Subjects with clinically significant concomitant diseases will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
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)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
St. Vincent's Health - Fitzroy
Recruitment hospital [7] 0 0
Western Hospital - Footscray
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [9] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [10] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Footscray
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment postcode(s) [8] 0 0
- Fremantle
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
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United States of America
State/province [11] 0 0
Mississippi
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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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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Ohio
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United States of America
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Oregon
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United States of America
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Tennessee
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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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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Mar del Plata
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Brazil
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PR
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Brazil
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Rio Grande Do Sul
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Brazil
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RJ
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Brazil
State/province [29] 0 0
Sao Paulo
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Brazil
State/province [30] 0 0
SP
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Brazil
State/province [31] 0 0
Belo Horizonte
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Canada
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Alberta
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Canada
State/province [33] 0 0
British Columbia
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Canada
State/province [34] 0 0
Nova Scotia
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
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China
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Hong Kong
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Greece
State/province [37] 0 0
Athens
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Puerto Rico
State/province [38] 0 0
Santurce
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Spain
State/province [39] 0 0
Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Songkhla
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Phitsanulok
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United Kingdom
State/province [51] 0 0
Glasgow
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United Kingdom
State/province [52] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pharmasset
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M. Michelle Berrey, MD, MPH
Address 0 0
Pharmasset
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00496002