NCT00262483

Brief Summary

To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2

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

December 1, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

December 2, 2005

Last Update Submit

December 17, 2007

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Safety of triple combination therapy.

    retrospective and prospective

Secondary Outcomes (2)

  • Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.

    retrospective and prospective

  • Plasma HCV RNA levels

    retrospective and prospective

Interventions

VX-950DRUG
ribavirinDRUG
peginterferon alfa-2aDRUG

Eligibility Criteria

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

You may qualify if:

  • Infected with hepatitis C virus

You may not qualify if:

  • Contraindications to peginterferon or ribavirin therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Call for information

San Antonio, Texas, United States

Location

Call for information

Santurce, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevirRibavirinpeginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Medical Monitor

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 6, 2005

Study Start

December 1, 2005

Study Completion

April 1, 2006

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

US(1)PR(1)