Clinical trial NCT00496002: Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Hepatitis
Hepatitis B
Keywords: Hepatitis B virus
Nucleoside Treatment-Naïve Patients with HBeAg Positive
Lead sponsor: Pharmasset
Sponsor class: INDUSTRY
First posted: 2007-07-04
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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.

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