Virology Follow up Study in Subjects Previously Treated With Telaprevir

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT00916474
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • telaprevir — DRUG

Study Details

Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.

Key Dates

First listed
Jun 9, 2009
Start date
Jun 30, 2009
Status verified
Feb 2014
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
408 participants (actual)

Arms

  • Arm: Cohort A
    Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time
  • Arm: Cohort B
    Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time

Primary Outcome Measure

Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment [ Time Frame: 3 years ]

Locations (25)

FacilityCityStateZIPSite coordinators
AlabamaBirminghamAlabama--
CaliforniaCoronadoCalifornia--
CaliforniaLos AngelesCalifornia--
CaliforniaSan FranciscoCalifornia--
ColoradoDenverColorado--
ColoradoEnglewoodColorado--
FloridaGainsvilleFlorida--
FloridaJacksonvilleFlorida--
FloridaMiamiFlorida--
GeorgiaAltantaGeorgia--
MarylandBaltimoreMaryland--
MassachusettsBostonMassachusetts--
MichiganNoviMichigan--
MissouriSt LouisMissouri--
New MexicoAlbuquerqueNew Mexico--
New YorkManhassetNew York--
New YorkNew YorkNew York--
North CarolinaChapel HillNorth Carolina--
North CarolinaDurhamNorth Carolina--
OhioCincinnatiOhio--
South CarolinaColumbiaSouth Carolina--
TexasHoustonTexas--
TexasSan AntonioTexas--
VirginiaFairfaxVirginia--
VirginiaFalls ChurchVirginia--

Find similar trials in Birmingham, AL

By research site
Alabama· Birmingham, ALCalifornia· Coronado, CACalifornia· Los Angeles, CACalifornia· San Francisco, CAColorado· Denver, COColorado· Englewood, CO

Related Studies