Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus

Hepatitis B Clinical Trial

— QUASH2  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00496158
• Other study ID #: CI-PSI-5268-06-306
• 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
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis, Chronic

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,