NCT00251199

Brief Summary

VX-950 is an investigational drug , which is being tested in combination with a known treatment for hepatitis C, peginterferon.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_1

Geographic Reach
2 countries

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, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

November 7, 2005

Last Update Submit

December 17, 2007

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Viral kinetics

Secondary Outcomes (1)

  • Assess the safety of VX-950 in combination with peginterferon

Interventions

VX-950DRUG
peginterferonDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • infected with Hepatitis C virus

You may not qualify if:

  • contraindications to peginterferon therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Call for information

Homburg/Saar, Germany

Location

Call for information

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Medical Monitor

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 9, 2005

Study Start

October 1, 2005

Study Completion

March 1, 2006

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

DE(1)NL(1)