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

Hepatitis C, Chronic Clinical Trial

— STEADFAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994486
• Other study ID #: 20132125
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2013
• Last updated: March 21, 2018
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: March 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	UF Hepatology Research at CTRB	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose	Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment	4/22/2014-5/6/2014
Primary	Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir	Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.	12 weeks-January 3, 2014- April 10, 2014
Primary	Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks	The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.	1/3/2014-4/10/2014
Secondary	Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007	Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.	1/17/2014-3/26/2014
Secondary	Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen	Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)	6/16/2014-7/2/2014
Secondary	Proportion of Subjects With Viral Relapse	Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point.	1/3/2014-9/8/2014