NCT00227435

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

September 26, 2005

Last Update Submit

April 25, 2016

Conditions

Chronic Hepatitis C

Interventions

val-mCydDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with HBV or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Pasadena, California, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

February 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

US(4)