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Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects

Phase I,Randomized,Double-blind,Placebo-controlled,Multiple Dose Study Evaluating Safety,Tolerability,Pharmacokinetics and Antiviral Activity of JTK-853 in HCV Genotype 1 Infected Subjects,Followed by a Genotypic Resistance Monitoring Study

NCT01473056•Akros Pharma Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
•2. Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
•3. Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)

Exclusion Criteria

•1. Subjects should not have previously received a direct acting anti-HCV agent
•2. Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks

Locations (1)

Fundacion de Investigacion de Diego

San Juan, Puerto Rico

Key Dates

Start Date

August 1, 2010

Primary Completion Date

October 1, 2010

Completion Date

September 1, 2011

Last Updated

November 21, 2011

Enrollment

ACTUAL participants

Conditions

Hepatitis C Virus Infection, Response to Therapy of

Interventions

JTK-853

DRUG

Dose 2 JTK-853

DRUG

Dose 3 JTK-853

DRUG

Dose 4 JTK-853

DRUG

Placebo

DRUG

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

NCT05361603

Hepatitis CTransmission, Intravenous Drug Abuser+3 more

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UNKNOWNNA

HCV Reinfection After DAA Therapy in PWID in Belgium

NCT04251572

Hepatitis C Virus Infection, Response to Therapy ofDrug Use

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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: November 21, 2011Data 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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Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

HCV Reinfection After DAA Therapy in PWID in Belgium

HCV Reinfection in HD Patients Achieving SVR

Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4

CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients