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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00496158




Registration number
NCT00496158
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 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 Negative Chronic Hepatitis Due to Hepatitis B Virus
Secondary ID [1] 0 0
CI-PSI-5268-06-306
Universal Trial Number (UTN)
Trial acronym
QUASH2
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
Treatment: Drugs - Clevudine
Treatment: Drugs - Adefovir

Treatment: Drugs: Clevudine


Treatment: Drugs: Adefovir


Intervention code [1] 0 0
Treatment: Drugs
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
negative hepatitis B infection (i.e., based on serological, virological and
histological markers) will be eligible for this study.

- Subjects entering the study with an historical biopsy will have chronic hepatic
inflammatory injury at screening (Knodell HAI score = 4 and modified Ishak fibrosis
score = 5).

- The number of subjects entering the study with an Ishak fibrosis score of 5 will be
limited to approximately 10%. 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
Gender
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
Terminated
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)
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 - 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
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Cordoba
Country [24] 0 0
Argentina
State/province [24] 0 0
Mar del Plata
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
China
State/province [29] 0 0
Hong Kong
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
Santurce
Country [32] 0 0
Spain
State/province [32] 0 0
Alicante
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Taiwan
State/province [35] 0 0
Kaohsiung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Tainan
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
Thailand
State/province [39] 0 0
Songkhla
Country [40] 0 0
Thailand
State/province [40] 0 0
Bangkok
Country [41] 0 0
Thailand
State/province [41] 0 0
Chiang Mai
Country [42] 0 0
Thailand
State/province [42] 0 0
Khon Kaen
Country [43] 0 0
Thailand
State/province [43] 0 0
Phitsanulok
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Glasgow
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the
efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as
monotherapy, for 48 weeks, 72 weeks, and 96 weeks.
Trial website
https://clinicaltrials.gov/show/NCT00496158
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00496158