- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120861
Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
June 9, 2010 updated by: Merck Sharp & Dohme LLC
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients.
These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States
-
-
California
-
Los Angeles, California, United States
-
San Francisco, California, United States
-
-
Florida
-
Miami, Florida, United States
-
-
Maryland
-
Baltimore, Maryland, United States
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
-
Michigan
-
Detroit, Michigan, United States
-
-
New York
-
New York, New York, United States
-
-
Texas
-
Dallas, Texas, United States
-
Houston, Texas, United States
-
San Antonio, Texas, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis B or HIV
Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Registration Dates
First Submitted
July 11, 2005
First Submitted That Met QC Criteria
July 18, 2005
First Posted (Estimate)
July 19, 2005
Study Record Updates
Last Update Posted (Estimate)
June 10, 2010
Last Update Submitted That Met QC Criteria
June 9, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Interferons
- Ribavirin
Other Study ID Numbers
- NV-08A-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis C
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hospices Civils de LyonCompleted
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis cChina
Clinical Trials on ribavirin
-
Institute of Liver and Biliary Sciences, IndiaTerminated
-
University of Roma La SapienzaCompleted
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Hoffmann-La RocheCompletedHealthy VolunteerMexico
-
University of BernRoche Pharma AG; University of Lausanne; University of Basel; Cantonal Hospital... and other collaboratorsCompleted
-
Janssen-Cilag International NVNo longer availableHepatitis CAustralia, Belgium, Germany, Spain, Switzerland, Romania, Serbia, Greece, New Zealand, Brazil, Russian Federation, Austria, Hungary, Czech Republic, Luxembourg
-
Conatus Pharmaceuticals Inc.Completed
-
National Institute of Diabetes and Digestive and...CompletedHepatitis C, ChronicUnited States
-
Memorial Sloan Kettering Cancer CenterCompletedHEAD & NECK CancerUnited States
-
Kaohsiung Medical University Chung-Ho Memorial...Completed