QUASH 1: Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
Sponsor
Pharmasset (Industry)
Overall Status
Terminated
CT.gov ID
NCT00496002
Collaborator
(none)
134
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Aug 1, 2007
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Birmingham | Birmingham | Alabama | United States | |
| 2 | Anaheim | California | United States | 92801 | |
| 3 | Advanced Clinical Research Institution | Anaheim | California | United States | |
| 4 | Fresno | California | United States | 93710 | |
| 5 | Fresno | California | United States | ||
| 6 | Los Angeles | California | United States | 90045 | |
| 7 | Cedars-Sinai Medical Center | Los Angeles | California | United States | |
| 8 | West Gastroenterology Medical Group | Los Angeles | California | United States | |
| 9 | Los Angeles | California | United States | ||
| 10 | San Clemente | California | United States | ||
| 11 | San Diego | California | United States | 92123 | |
| 12 | Medical Associates Research Group | San Diego | California | United States | |
| 13 | Sharp Rees-Stealy Medical Group Inc | San Diego | California | United States | |
| 14 | San Diego | California | United States | ||
| 15 | Quest Clinical Research | San Francisco | California | United States | 94115 |
| 16 | California Pacific Medical Center | San Francisco | California | United States | |
| 17 | Ucsf/Sfgh | San Francisco | California | United States | |
| 18 | San Mateo Medical Center | San Mateo | California | United States | |
| 19 | Norwich | Connecticut | United States | 06360 | |
| 20 | The William W. Backus Hospital | Norwich | Connecticut | United States | |
| 21 | Tampa | Florida | United States | 33614 | |
| 22 | Infectious Disease Research Institute, Inc. | Tampa | Florida | United States | |
| 23 | Tampa | Florida | United States | ||
| 24 | Liver Center | Honolulu | Hawaii | United States | |
| 25 | Memphis Gastroenterology Group | Germantown | Indiana | United States | |
| 26 | Iowa Health-Des Moines | Des Moines | Iowa | United States | |
| 27 | Tulane Medical Center | New Orleans | Louisiana | United States | |
| 28 | New Orleans | Louisiana | United States | ||
| 29 | Banks Hepatology Institute | College Park | Maryland | United States | |
| 30 | Boston | Massachusetts | United States | ||
| 31 | Digestive Health Specialists | Tupelo | Mississippi | United States | |
| 32 | Saint Louis University | St. Louis | Missouri | United States | |
| 33 | Hillsborough | New Jersey | United States | 08844 | |
| 34 | UMA Research Department | Binghamton | New York | United States | |
| 35 | Manhasset | New York | United States | ||
| 36 | Beth Israel Medical Center | New York | New York | United States | |
| 37 | VAMC/NYU | New York | New York | United States | |
| 38 | Weill Cornell Medical College | New York | New York | United States | |
| 39 | New York | New York | United States | ||
| 40 | Asheville | North Carolina | United States | 28801 | |
| 41 | Asheville Gastroenterology | Asheville | North Carolina | United States | |
| 42 | Duke University | Durham | North Carolina | United States | |
| 43 | Cincinnati | Ohio | United States | 45242 | |
| 44 | Cincinnati | Ohio | United States | ||
| 45 | Portland | Oregon | United States | 97220 | |
| 46 | Portland | Oregon | United States | 97239 | |
| 47 | Oregon Heath and Science University (OHSU) | Portland | Oregon | United States | |
| 48 | The Oregon Clinica P.C. | Portland | Oregon | United States | |
| 49 | Nashville Gastrointestinal Specialists, Inc | Nashville | Tennessee | United States | |
| 50 | Austin | Texas | United States | 78745 | |
| 51 | Austin Gastroenterology, PA | Austin | Texas | United States | |
| 52 | Baylor University Medical Center | Dallas | Texas | United States | |
| 53 | Methodist Transplant Physicians | Dallas | Texas | United States | |
| 54 | Galveston | Texas | United States | ||
| 55 | Houston | Texas | United States | 77028 | |
| 56 | Advanced Liver Therapies | Houston | Texas | United States | |
| 57 | Century Clinical Research, Inc. | Houston | Texas | United States | |
| 58 | Brooke Army Medical Center | San Antonio | Texas | United States | |
| 59 | Salt Lake City | Utah | United States | 84121 | |
| 60 | Salt Lake City | Utah | United States | ||
| 61 | University of Virginia | Charlottesville | Virginia | United States | |
| 62 | Fairfax | Virginia | United States | 22031 | |
| 63 | Metropolitan Research | Fairfax | Virginia | United States | |
| 64 | Richmond | Virginia | United States | ||
| 65 | Virginia Mason Medical Center | Seattle | Washington | United States | |
| 66 | Tacoma | Washington | United States | 98405 | |
| 67 | Centro De Hepatologia | Buenos Aires | Argentina | ||
| 68 | Funcei | Buenos Aires | Argentina | ||
| 69 | Fundacion Favaloro | Buenos Aires | Argentina | ||
| 70 | Hospital Aleman | Buenos Aires | Argentina | ||
| 71 | Hospital Britanico de Buenos Aires | Buenos Aires | Argentina | ||
| 72 | Hospital Universitario Austral | Buenos Aires | Argentina | ||
| 73 | Sanatorio de la Trinidad Mitre | Buenos Aires | Argentina | ||
| 74 | Sanatorio Guemes | Buenos Aires | Argentina | ||
| 75 | Sanatorio Dei Salvador | Cordoba | Argentina | ||
| 76 | H.I.G.A.O. Alende | Mar del Plata | Argentina | ||
| 77 | Concord Repatriation General Hospital | Concord | New South Wales | Australia | |
| 78 | Royal Prince Alfred Hospital | Sydney | New South Wales | Australia | |
| 79 | Princess Alexandra Hospital | Brisbane | Queensland | Australia | |
| 80 | Royal Brisbane and Women's Hospital | Brisbane | Queensland | Australia | |
| 81 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | |
| 82 | St. Vincent's Health | Fitzroy | Victoria | Australia | |
| 83 | Western Hospital | Footscray | Victoria | Australia | |
| 84 | Royal Melbourne Hospital | Melbourne | Victoria | Australia | |
| 85 | Fremantle Hospital | Fremantle | Western Australia | Australia | |
| 86 | Royal Perth Hospital | Perth | Western Australia | Australia | |
| 87 | Intituto A.Z. | Curitiba - PR | PR | Brazil | |
| 88 | Hospital de Clinicas De Porto Alegre - UFRGS | Porte Alegro | Rio Grande Do Sul | Brazil | |
| 89 | University of Rio de Janeiro Medical School Gaffree e Guinie University Hospital | Rio de Janeiro | RJ | Brazil | |
| 90 | PUC-Campinas | Campinas | Sao Paulo | Brazil | |
| 91 | School of Medicine of Ribeirao Preto-University of Sao Paulo | Ribeirao Preto | Sao Paulo | Brazil | |
| 92 | NICI Infectologia | Sorocaba | Sao Paulo | Brazil | |
| 93 | Facuidade de Medicina do ABC | Santo Andre | SP | Brazil | |
| 94 | Instituto de Ciencias do Hospital Alemao Oswaldo Cruz and Centro de Hepatologia de Sao Paulo | Sao Paulo | SP | Brazil | |
| 95 | Universidade Federal de Sao Paulo | Sao Paulo | SP | Brazil | |
| 96 | Santa Casa De Belo Horizonte | Belo Horizonte | Brazil | ||
| 97 | Instituto de Infectologia Emilio Ribas | Sao Paulo | Brazil | ||
| 98 | University of Calgary | Calgary | Alberta | Canada | |
| 99 | Liver and Intestinal Research Centre (LAIR Centre) | Vancouver | British Columbia | Canada | |
| 100 | UBC/Downtown ID Clinic | Vancouver | British Columbia | Canada | |
| 101 | Vancouver | British Columbia | Canada | ||
| 102 | Halifax | Nova Scotia | Canada | ||
| 103 | St. Joseph's Healthcare | Hamilton | Ontario | Canada | |
| 104 | London | Ontario | Canada | ||
| 105 | Ottawa | Ontario | Canada | ||
| 106 | Toronto | Ontario | Canada | ||
| 107 | The University of Hong Kong | Pok fu lam | Hong Kong | China | |
| 108 | The Chinese University of Hong Kong | Shatin | Hong Kong | China | |
| 109 | Alice Ho Miu Ling Nethersole Hospital | Tai Po | Hong Kong | China | |
| 110 | Agios Savvas Hospital | Athens | Greece | ||
| 111 | Ippokration General Hospital | Athens | Greece | ||
| 112 | Laiko General Hospital | Athens | Greece | ||
| 113 | Santurce | Puerto Rico | 00909 | ||
| 114 | Fundacion de Investigacion de Diego | Santurce | Puerto Rico | ||
| 115 | Hospital General Universitario de Alicant | Alicante | Spain | ||
| 116 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | ||
| 117 | Hospital Vall D'Hebron | Barcelona | Spain | ||
| 118 | Hospital Clinico San Carlos | Madrid | Spain | ||
| 119 | Hospital Universitario de La Princesa | Madrid | Spain | ||
| 120 | Hospital Universitario La Paz | Madrid | Spain | ||
| 121 | Hospital Universitario Puerta de Hierro | Madrid | Spain | ||
| 122 | Chang Gung Memorial Hospital Kaosiung | Kaohsiung | Taiwan | ||
| 123 | Chung-Ho Memorial Hospital, Kaohsiung Medical University Hospital | Kaohsiung | Taiwan | ||
| 124 | Taichung Veterans General Hospital | Taichung | Taiwan | ||
| 125 | National Cheng Kung University Hospital | Tainan | Taiwan | ||
| 126 | Taipei Veterans General Hospital | Taipei | Taiwan | ||
| 127 | NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital | Hat Yai | Songkhla | Thailand | |
| 128 | Phramongkutklao Hospital | Bangkok | Thailand | ||
| 129 | Siriraj Hosptial, Mahidol University | Bangkok | Thailand | ||
| 130 | Chang Mai University | Chiang Mai | Thailand | ||
| 131 | Srinagarind Hospital, Khon Kaen University | Khon Kaen | Thailand | ||
| 132 | Naresuan University | Phitsanulok | Thailand | ||
| 133 | Gartnavel General Hospital | Glasgow | United Kingdom | ||
| 134 | St. George's NHS Trust | London | United Kingdom |
Sponsors and Collaborators
- Pharmasset
Investigators
- Study Director: M. Michelle Berrey, MD, MPH, Pharmasset
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00496002
Other Study ID Numbers:
- CI-PSI-5268-06-305
First Posted:
Jul 4, 2007
Last Update Posted:
Apr 27, 2009
Last Verified:
Apr 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: