Clinical trial NCT01994486: Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
Official title: Open-Label Study to Evaluate the Safety and Tolerability of Telaprevir in Combination With Sofosbuvir in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: HCV Genotype 1
Hepatitis C Virus Genotype 1
HCV
TVR
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2013-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.

Detailed description: Starting on Day 1 and for up to 12 weeks, you will receive Telaprevir (TVR) and Sofosbuvir (SOF).

You will take one (1) 400 mg tablet of SOF and 3 tablets (1125 mg each) of TVR. You should take these together by mouth every morning. You will take another 3 tablets (1125 mg each) of TVR by mouth 12 hours after you take your morning dose.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent
* BMI (Body Mass Index) ≥ 18 kg/m2
* HCV RNA quantifiable at screening and \>1,000 IU/ml
* HCV treatment Naïve
* HCV genotype 1
* 7. Confirmation of chronic HCV infection documented by either: A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection

Exclusion Criteria:

* Current or prior history of any of the following:

Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant abnormalities

1. ALT \> 10 x the upper limit of normal (ULN)
2. AST \> 10 x ULN
3. Direct bilirubin \> 1.5 x ULN
4. Platelets \< 150,000/μL
5. HbA1c \> 7.5%
6. Creatinine clearance (CLcr) \< 60 mL /min, as calculated by the Cockcroft-Gault equation
7. Hemoglobin \< 11 g/dL for female subjects; \< 12 g/dL for male subjects.
8. Albumin \< 3.1 g/dL
9. INR \> 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 4. Prior exposure to any approved or experimental HCV-specific direct-acting

   5. Pregnant or nursing female or male with pregnant female partner.

   6. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).

   7. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Primary outcomes:
measure: Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir
timeFrame: 12 weeks-January 3, 2014- April 10, 2014
measure: Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks
timeFrame: 1/3/2014-4/10/2014
Secondary outcomes:
measure: Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007
timeFrame: 1/17/2014-3/26/2014
measure: Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen
timeFrame: 6/16/2014-7/2/2014
measure: Proportion of Subjects With Viral Relapse
timeFrame: 1/3/2014-9/8/2014
Other outcomes:
measure: Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose
timeFrame: 4/22/2014-5/6/2014
Locations:
city: Gainesville
country: United States
facility: UF Hepatology Research at CTRB
state: Florida
Study officials:
affiliation: University of Florida
name: DAVID R NELSON, MD
role: STUDY_DIRECTOR
References: