NCT01577069

Brief Summary

The purpose of the study is to 1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

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, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

April 12, 2012

Last Update Submit

June 21, 2016

Conditions

Chronic Hepatitis C

Keywords

Hepatitis CDirect Antiviral agent (DAA)Ultra-deep pyrosequencingSingle polynucleotide polymorphismsTreatment-resistant mutantsHepatitis C Virus Protease Inhibitor

Outcome Measures

Primary Outcomes (1)

  • virological resitance

    12 weeks after treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HCV mono-infected patients treated in the Hepatology Unit of Pr Victor de Lédinghen (Hôpital du Haut-Lévêque, Pessac)

You may qualify if:

  • HCV mono-infected subjects
  • Age \> 18 years

You may not qualify if:

  • HBV co-infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital du haut-Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Victor de lédinghen, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 13, 2012

Study Start

February 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

FR(1)