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

NCT01994486 | Completed Phase 2 Results DMC

• 1 other identifier: 20132125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Keywords

HCV Genotype 1; Hepatitis C Virus Genotype 1; HCV; TVR

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007

  1/17/2014-3/26/2014

• Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen

  6/16/2014-7/2/2014

• Proportion of Subjects With Viral Relapse

  1/3/2014-9/8/2014

Other Outcomes (1)

• Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose

  4/22/2014-5/6/2014

Study Arms (1)

Telaprevir and Sofosbuvir

EXPERIMENTAL

All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.

Drug: Telaprevir and Sofosbuvir

Interventions

Telaprevir and Sofosbuvir DRUG

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.

Also known as: TVR, SOF

Telaprevir and Sofosbuvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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

You may not qualify if:

• Current or prior history of any of the following:
• Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant abnormalities
• ALT \> 10 x the upper limit of normal (ULN)
• AST \> 10 x ULN
• Direct bilirubin \> 1.5 x ULN
• Platelets \< 150,000/μL
• HbA1c \> 7.5%
• Creatinine clearance (CLcr) \< 60 mL /min, as calculated by the Cockcroft-Gault equation
• Hemoglobin \< 11 g/dL for female subjects; \< 12 g/dL for male subjects.
• Albumin \< 3.1 g/dL
• 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
• \. Pregnant or nursing female or male with pregnant female partner.
• \. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).
• \. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Sponsors & Collaborators

• University of Florida: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (1)

UF Hepatology Research at CTRB

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

telaprevir; Sofosbuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Giuseppe (Joseph) Morelli, MD
• Organization: UNIVERSITY OF FLORIDA

GIUSEPPE.MORELLI@MEDICINE.UFL.EDU

352-273-9467

Study Officials

• DAVID R NELSON, MD

  University of Florida

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 23, 2018
• Results First Posted: March 6, 2015

Record last verified: 2018-03

Locations

US (1)