Simeprevir: all 77 studies that test it

Page 1 of 1. Open to participants first (0), then studies with results posted, then the rest; newest registration first within each.

• 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-naiveCompletedNCT02993250Phase 2Results posted
• Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C InfectionCompletedNCT02765490Phase 2Results posted
• A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and SimeprevirCompletedNCT02569710Phase 2Results posted
• 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 InfectionCompletedNCT02421211Phase 2Results posted
• Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative VolunteersCompletedNCT02404805Not applicableResults posted
• Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 InfectionCompletedNCT02349048Phase 2Results posted
• A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected ParticipantsCompletedNCT02268864Phase 2Results posted
• 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 DiseaseCompletedNCT02262728Phase 2Results posted
• Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus InfectionCompletedNCT02250807Phase 3Results posted
• The SIM-SOF Trial for Hepatitis CCompletedNCT02168361Phase 4Results posted
• Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without CirrhosisCompletedNCT02114177Phase 3Results posted
• Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and CirrhosisCompletedNCT02114151Phase 3Results posted
• An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected PatientsCompletedNCT01725529Phase 3Results posted
• 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 TherapyCompletedNCT01485991Phase 3Results posted
• 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 1CompletedNCT01479868Phase 3Results posted
• A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) InfectionCompletedNCT01366638Phase 3Results posted
• A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected PatientsCompletedNCT01292239Phase 3Results posted
• A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based TherapyCompletedNCT01290731Phase 3Results posted
• An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected ParticipantsCompletedNCT01290679Phase 3Results posted
• An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected PatientsCompletedNCT01289782Phase 3Results posted
• A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based TherapyCompletedNCT01288209Phase 3Results posted
• An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous TherapyCompletedNCT01281839Phase 3Results posted
• A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected PatientsCompletedNCT00996476Phase 2Results posted
• A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard TreatmentCompletedNCT00980330Phase 2Results posted
• 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 TreatmentCompletedNCT00882908Phase 2Results posted
• A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)CompletedNCT00812331Phase 2Results posted
• A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus InfectionCompletedNCT00561353Phase 2Results posted
• Effect of New Oral Treatment for Hepatitis C Virus on Seminal ParametersCompletedNCT05616598Phase 2/3
• Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian PatientsCompletedNCT04385407Phase 2
• Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir FailureCompletedNCT03549832Not applicable
• Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C InfectionCompletedNCT02992457Phase 4
• A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy ParticipantsCompletedNCT02945020Phase 1
• To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female ParticipantsCompletedNCT02885454Phase 1
• Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese ParticipantsCompletedNCT02824315Phase 1
• Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCCCompletedNCT02771405Phase 3
• Randomized Clinical Trial of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus Genotype 1 (TNT)CompletedNCT02624063Phase 4
• A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy VolunteersCompletedNCT02512562Phase 1
• Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1WithdrawnNCT02485080Phase 4
• 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.WithdrawnNCT02397395Phase 2
• A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult ParticipantsCompletedNCT02385071Phase 1
• An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus InfectionCompletedNCT02278419Phase 2
• Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus InfectionCompletedNCT02253550Phase 2
• A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis CWithdrawnNCT02206932Phase 4
• A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese ParticipantsCompletedNCT02071355Phase 1
• 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 ParticipantsCompletedNCT02064842Phase 1
• A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.CompletedNCT02018536Phase 1
• Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)CompletedNCT01907724Phase 1
• A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy VolunteersCompletedNCT01891851Phase 1
• A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV InfectionCompletedNCT01846832Phase 3
• Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)CompletedNCT01813513Phase 1
• A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435CompletedNCT01799603Phase 1
• 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 PatientsCompletedNCT01707342Phase 1
• A Pharmacokinetic Interaction Study Between TMC435, Atorvastatin and Simvastatin in Healthy ParticipantsCompletedNCT01689623Phase 1
• A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.CompletedNCT01571570Phase 1
• 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 PatientsCompletedNCT01567735Phase 3
• A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive OvysmenCompletedNCT01486004Phase 1
• A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and TacrolimusCompletedNCT01479881Phase 1
• TMC435-TiDP16-C126 - Trial to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics and Safety of TMC435CompletedNCT01381835Phase 1
• TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)CompletedNCT01323257Phase 1
• 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 StudyCompletedNCT01323244Phase 3
• TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect StudyCompletedNCT01308606Phase 1
• TMC435-TiDP16-C108 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Digoxin and Between TMC435 and RosuvastatinCompletedNCT01288742Phase 1
• TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy VolunteersCompletedNCT01269294Phase 1
• TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and RaltegravirCompletedNCT01241773Phase 1
• TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese VolunteersCompletedNCT01224197Phase 1
• TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and TenofovirCompletedNCT01205139Phase 1
• 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 PatientsCompletedNCT01202825Phase 1
• 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 AdministrationCompletedNCT01134718Phase 1
• TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun LightCompletedNCT01124799Phase 1
• TMC435-TiDP16-C112 - Interaction Trial With AntidepressantsCompletedNCT01090700Phase 1
• TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435CompletedNCT01046058Phase 1
• 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 TMC435CompletedNCT01022125Phase 1
• A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and MethadoneCompletedNCT00915564Phase 1
• 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.CompletedNCT00866853Phase 1
• TMC435350-TiDP16-C106: A Phase I Trial to Compare the Bioavailability and Plasma Pharmacokinetics After a Single Oral Dose of TMC435350 of 2 Different Solid Formulations Relative to a Powder Blend CapsuleCompletedNCT00752648Phase 1
• TMC435350-TiDP16-C109: A Safety Study for TMC435350 in an Oral Solution Containing Either 100, 200 or 400 mg Equivalent of TMC435350 or Placebo in Healthy Japanese Male VolunteersCompletedNCT00752544Phase 1
• TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.CompletedNCT00741169Phase 1

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