NCT00395421

Brief Summary

This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

2 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

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

1.7 years

First QC Date

November 1, 2006

Last Update Submit

June 9, 2010

Conditions

Chronic Hepatitis C

Keywords

treatment-naive

Study Arms (1)

A

EXPERIMENTAL

NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)

Drug: NM283 plus Peg-IFNα-2a

Interventions

NM283 plus Peg-IFNα-2aDRUG

200 mg QD 180 µg QW

A

Eligibility Criteria

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

You may qualify if:

  • Documented clinical history compatible with chronic hepatitis C and compensated liver disease
  • Has not previously received anti-viral therapy for hepatitis C infection

You may not qualify if:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis B virus and/or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

valopicitabine

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 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(2)