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Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus (QUASH 1)

Primary Purpose

Chronic Hepatitis, Hepatitis B

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clevudine
Adefovir
Sponsored by
Pharmasset
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis focused on measuring Hepatitis B virus, Nucleoside Treatment-Naïve Patients with HBeAg Positive

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • University of Alabama Birmingham
  • Advanced Clinical Research Institution
  • Cedars-Sinai Medical Center
  • West Gastroenterology Medical Group
  • Medical Associates Research Group
  • Sharp Rees-Stealy Medical Group Inc
  • Quest Clinical Research
  • California Pacific Medical Center
  • Ucsf/Sfgh
  • San Mateo Medical Center
  • The William W. Backus Hospital
  • Infectious Disease Research Institute, Inc.
  • Liver Center
  • Memphis Gastroenterology Group
  • Iowa Health-Des Moines
  • Tulane Medical Center
  • Banks Hepatology Institute
  • Digestive Health Specialists
  • Saint Louis University
  • UMA Research Department
  • Beth Israel Medical Center
  • VAMC/NYU
  • Weill Cornell Medical College
  • Asheville Gastroenterology
  • Duke University
  • Oregon Heath and Science University (OHSU)
  • The Oregon Clinica P.C.
  • Nashville Gastrointestinal Specialists, Inc
  • Austin Gastroenterology, PA
  • Baylor University Medical Center
  • Methodist Transplant Physicians
  • Advanced Liver Therapies
  • Century Clinical Research, Inc.
  • Brooke Army Medical Center
  • University of Virginia
  • Metropolitan Research
  • Virginia Mason Medical Center
  • Centro De Hepatologia
  • Funcei
  • Fundacion Favaloro
  • Hospital Aleman
  • Hospital Britanico de Buenos Aires
  • Hospital Universitario Austral
  • Sanatorio de la Trinidad Mitre
  • Sanatorio Guemes
  • Sanatorio Dei Salvador
  • H.I.G.A.O. Alende
  • Concord Repatriation General Hospital
  • Royal Prince Alfred Hospital
  • Princess Alexandra Hospital
  • Royal Brisbane and Women's Hospital
  • Royal Adelaide Hospital
  • St. Vincent's Health
  • Western Hospital
  • Royal Melbourne Hospital
  • Fremantle Hospital
  • Royal Perth Hospital
  • Intituto A.Z.
  • Hospital de Clinicas De Porto Alegre - UFRGS
  • University of Rio de Janeiro Medical School Gaffree e Guinie University Hospital
  • PUC-Campinas
  • School of Medicine of Ribeirao Preto-University of Sao Paulo
  • NICI Infectologia
  • Facuidade de Medicina do ABC
  • Instituto de Ciencias do Hospital Alemao Oswaldo Cruz and Centro de Hepatologia de Sao Paulo
  • Universidade Federal de Sao Paulo
  • Santa Casa De Belo Horizonte
  • Instituto de Infectologia Emilio Ribas
  • University of Calgary
  • Liver and Intestinal Research Centre (LAIR Centre)
  • UBC/Downtown ID Clinic
  • St. Joseph's Healthcare
  • The University of Hong Kong
  • The Chinese University of Hong Kong
  • Alice Ho Miu Ling Nethersole Hospital
  • Agios Savvas Hospital
  • Ippokration General Hospital
  • Laiko General Hospital
  • Fundacion de Investigacion de Diego
  • Hospital General Universitario de Alicant
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Vall D'Hebron
  • Hospital Clinico San Carlos
  • Hospital Universitario de La Princesa
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro
  • Chang Gung Memorial Hospital Kaosiung
  • Chung-Ho Memorial Hospital, Kaohsiung Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital
  • Phramongkutklao Hospital
  • Siriraj Hosptial, Mahidol University
  • Chang Mai University
  • Srinagarind Hospital, Khon Kaen University
  • Naresuan University
  • Gartnavel General Hospital
  • St. George's NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 2, 2007
Last Updated
April 23, 2009
Sponsor
Pharmasset
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1. Study Identification

Unique Protocol Identification Number
NCT00496002
Brief Title
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
Acronym
QUASH 1
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 Positive Chronic Hepatitis Due to Hepatitis B Virus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated in the interest of patient safety.
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmasset

4. Oversight

5. Study Description

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 and 96 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis, Hepatitis B
Keywords
Hepatitis B virus, Nucleoside Treatment-Naïve Patients with HBeAg Positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clevudine
Intervention Type
Drug
Intervention Name(s)
Adefovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Michelle Berrey, MD, MPH
Organizational Affiliation
Pharmasset
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Clinical Research Institution
City
Anaheim
State/Province
California
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
West Gastroenterology Medical Group
City
Los Angeles
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Clemente
State/Province
California
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group Inc
City
San Diego
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
Ucsf/Sfgh
City
San Francisco
State/Province
California
Country
United States
Facility Name
San Mateo Medical Center
City
San Mateo
State/Province
California
Country
United States
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
The William W. Backus Hospital
City
Norwich
State/Province
Connecticut
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Infectious Disease Research Institute, Inc.
City
Tampa
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Liver Center
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Indiana
Country
United States
Facility Name
Iowa Health-Des Moines
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Banks Hepatology Institute
City
College Park
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Digestive Health Specialists
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
Country
United States
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
UMA Research Department
City
Binghamton
State/Province
New York
Country
United States
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
VAMC/NYU
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Asheville Gastroenterology
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Heath and Science University (OHSU)
City
Portland
State/Province
Oregon
Country
United States
Facility Name
The Oregon Clinica P.C.
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Nashville Gastrointestinal Specialists, Inc
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Austin Gastroenterology, PA
City
Austin
State/Province
Texas
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Methodist Transplant Physicians
City
Dallas
State/Province
Texas
Country
United States
City
Galveston
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77028
Country
United States
Facility Name
Advanced Liver Therapies
City
Houston
State/Province
Texas
Country
United States
Facility Name
Century Clinical Research, Inc.
City
Houston
State/Province
Texas
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Centro De Hepatologia
City
Buenos Aires
Country
Argentina
Facility Name
Funcei
City
Buenos Aires
Country
Argentina
Facility Name
Fundacion Favaloro
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Aleman
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio de la Trinidad Mitre
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Guemes
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Dei Salvador
City
Cordoba
Country
Argentina
Facility Name
H.I.G.A.O. Alende
City
Mar del Plata
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
St. Vincent's Health
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Intituto A.Z.
City
Curitiba - PR
State/Province
PR
Country
Brazil
Facility Name
Hospital de Clinicas De Porto Alegre - UFRGS
City
Porte Alegro
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
University of Rio de Janeiro Medical School Gaffree e Guinie University Hospital
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Facility Name
PUC-Campinas
City
Campinas
State/Province
Sao Paulo
Country
Brazil
Facility Name
School of Medicine of Ribeirao Preto-University of Sao Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
Country
Brazil
Facility Name
NICI Infectologia
City
Sorocaba
State/Province
Sao Paulo
Country
Brazil
Facility Name
Facuidade de Medicina do ABC
City
Santo Andre
State/Province
SP
Country
Brazil
Facility Name
Instituto de Ciencias do Hospital Alemao Oswaldo Cruz and Centro de Hepatologia de Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Santa Casa De Belo Horizonte
City
Belo Horizonte
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas
City
Sao Paulo
Country
Brazil
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Liver and Intestinal Research Centre (LAIR Centre)
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
UBC/Downtown ID Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
The University of Hong Kong
City
Pok fu lam
State/Province
Hong Kong
Country
China
Facility Name
The Chinese University of Hong Kong
City
Shatin
State/Province
Hong Kong
Country
China
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
State/Province
Hong Kong
Country
China
Facility Name
Agios Savvas Hospital
City
Athens
Country
Greece
Facility Name
Ippokration General Hospital
City
Athens
Country
Greece
Facility Name
Laiko General Hospital
City
Athens
Country
Greece
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Fundacion de Investigacion de Diego
City
Santurce
Country
Puerto Rico
Facility Name
Hospital General Universitario de Alicant
City
Alicante
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Vall D'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Chang Gung Memorial Hospital Kaosiung
City
Kaohsiung
Country
Taiwan
Facility Name
Chung-Ho Memorial Hospital, Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital
City
Hat Yai
State/Province
Songkhla
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hosptial, Mahidol University
City
Bangkok
Country
Thailand
Facility Name
Chang Mai University
City
Chiang Mai
Country
Thailand
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
Country
Thailand
Facility Name
Naresuan University
City
Phitsanulok
Country
Thailand
Facility Name
Gartnavel General Hospital
City
Glasgow
Country
United Kingdom
Facility Name
St. George's NHS Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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