Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a drug is absorbed and distributed in the body), and intrinsic antiviral activity of JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus (HCV)-genotype-1-infected patients at different doses and dose regimens.


Clinical Trial Description

This is a double-blind (neither physician nor patient knows the name of the assigned drug), randomized (patients are assigned by chance to treatment groups) placebo-controlled study. A placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The study population will consist of Asian treatment-naive genotype-1, chronic HCV-infected patients. The trial will involve a screening period at a maximum of 6 weeks before baseline, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. Patients will be divided into 3 panels of 8 patients (Panel 1) or 5 patients (Panels 2 and 3). Treatment will be initiated in each panel of patients sequentially. In each panel, patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382, or placebo, will be administered once daily. Treatments will be taken by mouth and with standardized meals in all dosing regimens. Patient safety will be monitored. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01586325
Study type Interventional
Source Janssen R&D Ireland
Contact
Status Terminated
Phase Phase 1
Start date May 25, 2012
Completion date April 21, 2014

See also
  Status Clinical Trial Phase
Completed NCT02219503 - A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis Phase 3
Completed NCT02216422 - A Study to Evaluate Chronic Hepatitis C Infection in Cirrhotic Adults With Genotype 1b Infection Phase 3
Completed NCT01700179 - Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants Phase 1
Completed NCT02486406 - A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects Phase 2/Phase 3
Completed NCT01704755 - A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis Phase 3
Completed NCT01225380 - A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C Phase 2
Completed NCT01221298 - A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) Phase 2
Completed NCT01715415 - A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults Phase 3
Completed NCT01716585 - A Study to Evaluate Chronic Hepatitis C Infection Phase 3
Completed NCT02065999 - Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
Completed NCT01453075 - Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I) Phase 1
Completed NCT01011166 - Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004) Phase 2
Completed NCT00557583 - Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults Phase 1
Recruiting NCT02578693 - Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)
Recruiting NCT02583685 - Switching Regimen in Treating Cirrhotic HCV GT1b Subjects Phase 2
Completed NCT02576314 - Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients Phase 3
Not yet recruiting NCT01835938 - Clinical Investigation of Erlotinib as an HCV Entry Inhibitor Phase 1/Phase 2
Completed NCT01055821 - Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients Phase 2
Completed NCT01833533 - A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection Phase 3
Completed NCT01854697 - A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before Phase 3