Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

September 30, 2014

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Telaprevir and Sofosbuvir

All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.

Trial Locations (1)

32610

UF Hepatology Research at CTRB, Gainesville

All Listed Sponsors
collaborator

Vertex Pharmaceuticals Incorporated

INDUSTRY

lead

University of Florida

OTHER

NCT01994486 - Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1 | Biotech Hunter | Biotech Hunter