Search clinical trials for: Simeprevir (TMC435)

Total 130 results

Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

Hepatitis C Virus
Janssen R&D Ireland

Completed

A Study to Assess the Absolute Bioavailability and Pharmacokinetics of Simeprevir (TMC435) Administered as Single Oral Doses of TMC435 and an Intravenous Microdose of [3H]-TMC435 in Healthy Male Patients

Healthy Male Participants

Belgium
Janssen Research & Development, LLC

Completed

A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese Participants

Healthy

China
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study

Hepatitis C
University of California, San Francisco
Janssen Scientific Affairs, LLC

Withdrawn

A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C

Hepatitis C, Chronic | HIV CDC Category A1

United States
Janssen R&D Ireland

Completed

A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.

Healthy Volunteers

United Kingdom
Janssen R&D Ireland

Completed

A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients (RESTORE)

Hepatitis C

France, Belgium
Tibotec Pharmaceuticals, Ireland

Completed

TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers

Hepatitis C

Hong Kong
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435

Hepatitis C Virus

United States
Janssen R&D Ireland

Completed

A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study

Hepatitis C

United States, Australia, France, Ukraine, United Kingdom, Belgium, Germany, Spain, Israel, Portugal, Bulgaria, Netherlands, Canada, New Zealand, Russian Federation, Argentina, Brazil, Puerto Rico, Austria, Poland, Romania, Mexico
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir

Hepatitis C Virus
Janssen Pharmaceutical K.K.

Completed

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

Hepatitis C, Chronic

Japan
Tibotec Pharmaceuticals, Ireland

Completed

A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

Hepatitis C

Belgium, Germany, Thailand
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

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

Hepatitis C Virus

Czech Republic
Janssen Research & Development, LLC

Completed

A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435

Healthy

Japan
Janssen R&D Ireland

Completed

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Chronic Hepatitis C | Genotype 4 Chronic Hepatitis C

Spain
Janssen R&D Ireland

Completed

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy (ATTAIN)

Hepatitis C

United States, Australia, France, Poland, United Kingdom, Germany, Spain, Belgium, Israel, Portugal, Bulgaria, Romania, Denmark, Greece, Sweden, Canada, Czech Republic, Argentina, Brazil, Austria, Hungary, Switzerland, Puerto Rico, No...
Tibotec Pharmaceuticals, Ireland

Completed

TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients

Hepatitis C

Belgium
Janssen Pharmaceutical K.K.

Completed

A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients (DRAGON)

Hepatitis C, Chronic

Japan
Bristol-Myers Squibb
Janssen Research & Development, LLC

Completed

Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus

Hepatitis C Virus

Argentina, France, United States, Spain, Germany, Hungary
Tibotec Pharmaceuticals, Ireland

Completed

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

Hepatitis C Virus

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins.

Hepatitis C | Viruses
Janssen Research & Development, LLC

Completed

An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Hepatitis C, Chronic

United States
Peter J. Ruane, M.D.
Janssen Scientific Affairs, LLC

Completed

Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

Chronic Hepatitis C

United States
Janssen R&D Ireland
Gilead Sciences

Completed

A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients (COSMOS)

Hepatitis C

United States, Puerto Rico
Tibotec Pharmaceuticals, Ireland

Completed

A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection

Hepatitis C, Chronic

France, United Kingdom, Belgium, Germany, Poland, Netherlands
Janssen R&D Ireland

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.

Healthy

United States
Janssen R&D Ireland

Completed

An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

Hepatitis C, Chronic

China, Korea, Republic of
Janssen Research & Development, LLC

Completed

A Pharmacokinetic Interaction Study Between TMC435, Atorvastatin and Simvastatin in Healthy Participants

Healthy Participants

United States
Tibotec Pharmaceuticals, Ireland

Completed

A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment (PILLAR)

Hepatitis C

United States, Australia, France, Belgium, Germany, Spain, Denmark, Canada, New Zealand, Russian Federation, Austria, Poland, Norway
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir

Hepatitis C Virus

Germany
Janssen Pharmaceutical K.K.

Completed

A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

Hepatitis C, Chronic

Japan
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers

Hepatitis C
Janssen R&D Ireland

Completed

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients (QUEST-1)

Hepatitis C

United States, Australia, Ukraine, United Kingdom, Germany, Spain, Mexico, Canada, New Zealand, Russian Federation, Puerto Rico, Romania
Janssen Pharmaceutical K.K.

Completed

A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

Hepatitis C, Chronic

Japan
Janssen Pharmaceutical K.K.

Completed

A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection

Hepatitis C, Chronic

Japan
Janssen Pharmaceutical K.K.

Completed

A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy

Hepatitis C, Chronic

Japan
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment (ASPIRE)

Hepatitis C

United States, Australia, France, United Kingdom, Belgium, Germany, Israel, Portugal, Canada, New Zealand, Russian Federation, Austria, Poland, Norway
Janssen R&D Ireland

Completed

An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy (PROMISE)

Hepatitis C

United States, Australia, France, Poland, United Kingdom, Belgium, Germany, Spain, Canada, New Zealand, Russian Federation, Puerto Rico, Austria
Tibotec Pharmaceuticals, Ireland

Completed

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

Hepatitis C Virus

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C112 - Interaction Trial With Antidepressants

Hepatitis C Virus
Janssen R&D Ireland

Completed

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants

Healthy

United Kingdom
Beni-Suef University

Completed

Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Chronic Hepatitis C Virus Infection
Tibotec Pharmaceuticals, Ireland

Completed

A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone

Hepatitis C

Canada
Janssen R&D Ireland

Withdrawn

An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

Renal Impairment | End-stage Renal Disease

France, Spain
Ain Shams University

Completed

Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

HCV
Janssen R&D Ireland

Completed

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

Hepatitis C Virus Genotype-1

United States, France, United Kingdom, Germany, Spain, Portugal, Canada, Puerto Rico
Janssen Sciences Ireland UC

Completed

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Hepatitis C, Chronic

Belgium

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