Chronic HepatitisPhase 3QUASH2NCT00496158
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
A Phase 3 study testing Clevudine and Adefovir in people with Chronic Hepatitis and Hepatitis B, run by Pharmasset at 119 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Hepatitis, Hepatitis B
- What is being tested?
- Clevudine and Adefovir
- How many people
- Not given
- Where
- 119 sitesin 11 countries
- Study dates
- Aug 2007to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
119 sites in 11 countries.
119 sites in 11 countries
United States63 sites
Study site
Anaheim, California, 92801
Advanced Clinical Research Institution
Anaheim, California
Study site
Asheville, North Carolina, 28801
Asheville Gastroenterology
Asheville, North Carolina
Study site
Austin, Texas, 78745
Austin Gastroenterology, PA
Austin, Texas
UMA Research Department
Binghamton, New York
University of Alabama Birmingham
Birmingham, Alabama
Study site
Boston, Massachusetts
University of Virginia
Charlottesville, Virginia
Study site
Cincinnati, Ohio, 45242
Study site
Cincinnati, Ohio
Banks Hepatology Institute
College Park, Maryland
Baylor University Medical Center
Dallas, Texas
Methodist Transplant Physicians
Dallas, Texas
Iowa Health-Des Moines
Des Moines, Iowa
Duke University
Durham, North Carolina
Study site
Fairfax, Virginia, 22031
Metropolitan Research
Fairfax, Virginia
Study site
Fresno, California, 93710
Study site
Fresno, California
Study site
Galveston, Texas
Memphis Gastroenterology Group
Germantown, Tennessee
Study site
Hillsborough, New Jersey, 08844
Liver Center
Honolulu, Hawaii
Advanced Liver Therapies
Houston, Texas, 77028
Century Clinical Research Inc
Houston, Texas
West Gastroenterology Medical Group
Los Angeles, California, 90045
Cedars-Sinai Medical Center
Los Angeles, California
Study site
Los Angeles, California
Study site
Manhasset, New York
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee
Tulane Medical Center
New Orleans, Louisiana
Study site
New Orleans, Louisiana
Beth Israel Medical Center
New York, New York
VAMC/NYU
New York, New York
Weill Cornell Medical College
New York, New York
Study site
New York, New York
Study site
North Miami Beach, Florida, 33162
The William W. Backus Hospital
Norwich, Connecticut, 06360
Oregon Health & Science University (OHSU)
Portland, Oregon, 97220
Study site
Portland, Oregon, 97239
The Oregon Clinic P.C.
Portland, Oregon
Study site
Richmond, Virginia
Study site
Salt Lake City, Utah, 84121
Study site
Salt Lake City, Utah
Brooke Army Mecial Center
San Antonio, Texas
Study site
San Clemente, California
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92123
Medical Associates Research Group
San Diego, California
Study site
San Diego, California
Study site
San Francisco, California, 94115
California Pacific Medical Center
San Francisco, California
Quest Clinical Research
San Francisco, California
Ucsf/Sfgh
San Francisco, California
San Mateo Medical Center
San Mateo, California
Virginia Mason Medical Center
Seattle, Washington
Saint Louis University
St Louis, Missouri
Study site
Tacoma, Washington, 98405
Study site
Tampa, Florida, 33614
Infectious Disease Reseach Institute, Inc
Tampa, Florida
Study site
Tampa, Florida
Digestive Health Specialists
Tupelo, Mississippi
Argentina10 sites
Centro de Hepatologia
Buenos Aires
Funcei
Buenos Aires
Fundacion Favaloro
Buenos Aires
Hospital Aleman
Buenos Aires
Hospital Britanico de Buenos Aires
Buenos Aires
Hospital Universitario Austral
Buenos Aires
Sanatorio de la Trinidad Mitre
Buenos Aires
Sanatorio Guemes
Buenos Aires
Sanatorio Dei Salvador
Córdoba
H.I.G.A O. Alende
Mar del Plata
Australia10 sites
Royal Adelaide Hospital
Adelaide, South Australia
Princess Alexandra Hospital
Brisbane, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland
Concord Repatriation General Hospital
Concord, New South Wales
St. Vincent's
Fitzroy, Victoria
Western Hospital
Footscray, Victoria
Fremantle Hospital
Fremantle, Western Australia
Royal Melbourne Hospital
Melbourne, Victoria
Royal Perth Hospital
Perth, Western Australia
Royal Prince Alfred Hospital
Sydney, New South Wales
Canada9 sites
University of Calgary
Calgary, Alberta
Study site
Halifax, Nova Scotia
St. Joseph's Healthcare
Hamilton, Ontario
Study site
London, Ontario
Study site
Ottawa, Ontario
Study site
Toronto, Ontario
Liver and Intestinal Research Center (LAIR Center)
Vancouver, British Columbia
UBC/ Downtown ID Clinic
Vancouver, British Columbia
Study site
Vancouver, British Columbia
Spain7 sites
Hospital General Universitario de Alicante
Alicante
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital Universitario de La Princesa
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Thailand6 sites
Phramongkutklao Hospital
Bangkok
Siriraj Hospital, Mahidol University
Bangkok
Chiang Mai University
Chiang Mai
NKC Institute of Gastroenterology and Hepatology/ Songklanagarind Hospital
Hat Yai, Changwat Songkhla
Srinagarind Hospital, Khon Kaen University
Khon Kaen
Naresuan University
Phitsanulok
Taiwan5 sites
Chang Gung Memorial Hospital Kaosiung
Kaohsiung City
Kaohsiung Medical University Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
China3 sites
Alice Ho Miu Ling Nethersole Hospital
Hong Kong
The Chinese University of Hong Kong
Hong Kong
The University of Hong Kong
Hong Kong
Greece3 sites
Agios Savvas Hospital
Athens
Ippokration General Hospital
Athens
Laiko General Hospital
Athens
United Kingdom2 sites
Gartnavel General Hospital
Glasgow
St. George's NHS Trust
London
About this study
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
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.
- Conditions
- Chronic Hepatitis, Hepatitis B
- Being tested
- Clevudine, Adefovir
- Keywords
- Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus, hepatitis b virus
- Medical subject headings
- Hepatitis, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevudineDrug
AdefovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startAug 2007
Why it stopped: The study was terminated in the interest of patient safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pharmasset
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- M Michelle Berrey, MD, MPH, Study director, Pharmasset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496158
- Sponsor's protocol ID
- CI-PSI-5268-06-306
- Acronym
- QUASH2
- Status last verified
- Apr 2009
- First submitted
- 2 Jul 2007
- Last updated
- 27 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00496158
- Acronym / sponsor ID
- QUASH2 / CI-PSI-5268-06-306
- Conditions
- Chronic Hepatitis, Hepatitis B
- Keywords
- Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus, hepatitis b virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated in the interest of patient safety.
- Lead sponsor
- PharmassetIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- First posted
- 4 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clevudine | Drug | – |
| Adefovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The study was terminated in the interest of patient safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Michelle Berrey, MD, MPH study director
Pharmasset
119 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clevudine and Adefovir in people with Chronic Hepatitis and Hepatitis B, run by Pharmasset at 119 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States, Argentina, Australia, Canada, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated in the interest of patient safety.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2009.