Clinical trial NCT00496158: Efficacy and Safety of Clevudine Compared With Adefovir in Patients With 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 Negative Chronic Hepatitis Due to Hepatitis B Virus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Hepatitis
Hepatitis B
Keywords: Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus
hepatitis b virus
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, 72 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 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.

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
facility: West Gastroenterology Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
state: California
city: San Clemente
country: United States
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
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
facility: The William W. Backus Hospital
state: Connecticut
city: North Miami Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Reseach Institute, Inc
state: Florida
city: Tampa
country: United States
state: Florida
city: Honolulu
country: United States
facility: Liver Center
state: Hawaii
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
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
facility: The Oregon Clinic P.C.
state: Oregon
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
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
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 Mecial 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
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: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Liver and Intestinal Research Center (LAIR Center)
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: Hong Kong
country: China
facility: Alice Ho Miu Ling Nethersole Hospital
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
city: Hong Kong
country: China
facility: The University of 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
facility: Fundacion de Investigacion de Diego
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
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: 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 Hospital, Mahidol University
city: Chiang Mai
country: Thailand
facility: Chiang 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: