- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00227435
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C
April 25, 2016 updated by: Merck Sharp & Dohme LLC
A Phase I/II Double-Blind, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Val-mCyd (NM283) in Adults With Chronic Hepatitis C
This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
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
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California
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Pasadena, California, United States
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Massachusetts
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Virginia
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Fairfax, Virginia, United States
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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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented clinical history of chronic hepatitis C and compensated liver disease
- No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient is co-infected with HBV 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: Double
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
February 1, 2003
Primary Completion (Actual)
July 1, 2004
Study Completion (Actual)
July 1, 2004
Study Registration Dates
First Submitted
September 26, 2005
First Submitted That Met QC Criteria
September 26, 2005
First Posted (Estimate)
September 28, 2005
Study Record Updates
Last Update Posted (Estimate)
April 27, 2016
Last Update Submitted That Met QC Criteria
April 25, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
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
Other Study ID Numbers
- NV-08A-001
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.
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Hospices Civils de LyonCompleted
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Sohag UniversityRecruiting
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Beni-Suef UniversityCompletedChronic Hepatitis C Virus InfectionEgypt
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Humanity and Health Research CentreBeijing 302 HospitalCompletedChronic Hepatitis C InfectionChina
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AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States, Puerto Rico
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Janssen R&D IrelandTerminated
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Beni-Suef UniversityCompletedChronic Hepatitis C Virus Infection
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