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Hepatitis C Virus clinical trials

View clinical trials related to Hepatitis C Virus.

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NCT ID: NCT01573351 Completed - Hepatitis C Virus Clinical Trials

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

Hallmark QUAD
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

NCT ID: NCT01486004 Completed - Hepatitis C Virus Clinical Trials

A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen

Start date: November 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and norethindrone (administered once a day) and on the levels of progesterone, luteinizing hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen. Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen will be studied. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.

NCT ID: NCT01479881 Completed - Hepatitis C Virus Clinical Trials

A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus

Start date: October 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the single-dose pharmacokinetics of the immunosuppressants cyclosporine and tacrolimus in healthy participants. Cyclosporine and tacrolimus are immunosuppressants used to prevent transplant rejection and may therefore potentially be coadministered with TMC435 in patients infected with hepatitis C virus that undergo liver transplantation. We will also explore the short-term safety and tolerability following coadministration of TMC435 at steady-state and (1) cyclosporine or (2) tacrolimus after single dosing in healthy participants. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

NCT ID: NCT01458535 Completed - Hepatitis C Virus Clinical Trials

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

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Start date: October 2011
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) when given together with ABT-267 and with and without Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection.

NCT ID: NCT01428063 Completed - Hepatitis C Virus Clinical Trials

Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide anti-HCV drugs to +/- 200 subjects treated in prior BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition of these drugs can result in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received placebo will be treated with active drugs in this study.

NCT ID: NCT01396005 Completed - Hepatitis C Virus Clinical Trials

A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)

Start date: September 2011
Phase: Phase 1
Study type: Interventional

In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.

NCT ID: NCT01381835 Completed - Hepatitis C Virus Clinical Trials

TMC435-TiDP16-C126 - Trial to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics and Safety of TMC435

Start date: July 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the steady-state pharmacokinetics of TMC435 in participants with severe renal impairment and to compare these with the TMC435 pharmacokinetics in matched participants with normal renal function. We will also study the short-term safety and tolerability of TMC435, when administered in participants with severe renal impairment and in participants with normal renal function. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

NCT ID: NCT01323257 Completed - Hepatitis C Virus Clinical Trials

TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of steady-state concentrations of erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a steady-state concentration of TMC435 (150 mg) on the steady-state pharmacokinetics of erythromycin and the effect of a steady-state concentration of TMC435 (50 mg) on the steady-state pharmacokinetics of DRV/r. We will also study the short-term safety and tolerability of TMC435 given alone and given togehter with erythromycin (Panel 1) or DRV/r (Panel 2). Steady state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

NCT ID: NCT01306617 Completed - Hepatitis C Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

NCT ID: NCT01288742 Completed - Hepatitis C Virus Clinical Trials

TMC435-TiDP16-C108 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Digoxin and Between TMC435 and Rosuvastatin

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the single-dose pharmacokinetics of digoxin or rosuvastatin , and the effect of a single dose of digoxin or rosuvastatin on the steady-state pharmacokinetics of TMC435. Steady state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.