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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00496158
Other study ID # CI-PSI-5268-06-306
Secondary ID
Status Terminated
Phase Phase 3
First received July 2, 2007
Last updated April 23, 2009
Start date August 2007

Study information

Verified date April 2009
Source Pharmasset
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Clevudine

Adefovir


Locations

Country Name City State
Argentina Centro de Hepatologia Buenos Aires
Argentina Funcei Buenos Aires
Argentina Fundacion Favaloro Buenos Aires
Argentina Hospital Aleman Buenos Aires
Argentina Hospital Britanico de Buenos Aires Buenos Aires
Argentina Hospital Universitario Austral Buenos Aires
Argentina Sanatorio de la Trinidad Mitre Buenos Aires
Argentina Sanatorio Guemes Buenos Aires
Argentina Sanatorio Dei Salvador Cordoba
Argentina H.I.G.A O. Alende Mar del Plata
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Princess Alexandra Hospital Brisbane Queensland
Australia Royal Brisbane and Women's Hospital Brisbane Queensland
Australia Concord Repatriation General Hospital Concord New South Wales
Australia St. Vincent's Fitzroy Victoria
Australia Western Hospital Footscray Victoria
Australia Fremantle Hospital Fremantle Western Australia
Australia Royal Melbourne Hospital Melbourne Victoria
Australia Royal Perth Hospital Perth Western Australia
Australia Royal Prince Alfred Hospital Sydney New South Wales
Canada University of Calgary Calgary Alberta
Canada St. Joseph's Healthcare Hamilton Ontario
Canada Liver and Intestinal Research Center (LAIR Center) Vancouver British Columbia
Canada UBC/ Downtown ID Clinic Vancouver British Columbia
China Alice Ho Miu Ling Nethersole Hospital Hong Kong
China The Chinese University of Hong Kong Hong Kong
China The University of Hong Kong Hong Kong
Greece Agios Savvas Hospital Athens
Greece Ippokration General Hospital Athens
Greece Laiko General Hospital Athens
Puerto Rico Fundacion de Investigacion de Diego Santurce
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro Madrid
Taiwan Chang Gung Memorial Hospital Kaosiung Kaohsiung
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Taipei Veterans General Hospital Taipei
Thailand Phramongkutklao Hospital Bangkok
Thailand Siriraj Hospital, Mahidol University Bangkok
Thailand Chiang Mai University Chiang Mai
Thailand NKC Institute of Gastroenterology and Hepatology/ Songklanagarind Hospital Hat Yai Songkhla
Thailand Srinagarind Hospital, Khon Kaen University Khon Kaen
Thailand Naresuan University Phitsanulok
United Kingdom Gartnavel General Hospital Glasgow
United Kingdom St. George's NHS Trust London
United States Advanced Clinical Research Institution Anaheim California
United States Asheville Gastroenterology Asheville North Carolina
United States Austin Gastroenterology, PA Austin Texas
United States UMA Research Department Binghamton New York
United States University of Alabama Birmingham Birmingham Alabama
United States University of Virginia Charlottesville Virginia
United States Banks Hepatology Institute College Park Maryland
United States Baylor University Medical Center Dallas Texas
United States Methodist Transplant Physicians Dallas Texas
United States Iowa Health-Des Moines Des Moines Iowa
United States Duke University Durham North Carolina
United States Metropolitan Research Fairfax Virginia
United States Memphis Gastroenterology Group Germantown Tennessee
United States Liver Center Honolulu Hawaii
United States Advanced Liver Therapies Houston Texas
United States Century Clinical Research Inc Houston Texas
United States Cedars-Sinai Medical Center Los Angeles California
United States West Gastroenterology Medical Group Los Angeles California
United States Nashville Gastrointestinal Specialists, Inc Nashville Tennessee
United States Tulane Medical Center New Orleans Louisiana
United States Beth Israel Medical Center New York New York
United States VAMC/NYU New York New York
United States Weill Cornell Medical College New York New York
United States The William W. Backus Hospital Norwich Connecticut
United States Oregon Health & Science University (OHSU) Portland Oregon
United States The Oregon Clinic P.C. Portland Oregon
United States Brooke Army Mecial Center San Antonio Texas
United States Medical Associates Research Group San Diego California
United States Sharp Rees-Stealy Medical Group, Inc. San Diego California
United States California Pacific Medical Center San Francisco California
United States Quest Clinical Research San Francisco California
United States Ucsf/Sfgh San Francisco California
United States San Mateo Medical Center San Mateo California
United States Virginia Mason Medical Center Seattle Washington
United States Saint Louis University St. Louis Missouri
United States Infectious Disease Reseach Institute, Inc Tampa Florida
United States Digestive Health Specialists Tupelo Mississippi

Sponsors (1)

Lead Sponsor Collaborator
Pharmasset

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  China,  Greece,  Puerto Rico,  Spain,  Taiwan,  Thailand,  United Kingdom, 

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