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Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01994486•University of Florida

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

UF Hepatology Research at CTRB

Gainesville, Florida, United States

Key Dates

Start Date

December 1, 2013

Primary Completion Date

April 1, 2014

Completion Date

September 1, 2014

Last Updated

April 23, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

Telaprevir and Sofosbuvir

DRUG

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

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The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection