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Showing 1–24 of 33 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Simeprevir Clear all
Completed Phase 2 Interventional

An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

NCT02165189
View directory record Official record
Conditions
Hepatitits C
Interventions
Simeprevir, Sofosbuvir, Ribavirin
Drug
Lead sponsor
Janssen Scientific Affairs, LLC
Industry
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
11
States / cities
Aurora, Colorado • Gainesville, Florida • Miami, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Nov 10, 2016 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 2 Interventional

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

NCT02253550
View directory record Official record
Conditions
Chronic Hepatitis C
Interventions
Simeprevir, Sofosbuvir
Drug
Lead sponsor
Peter J. Ruane, M.D.
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Feb 23, 2016 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

NCT02114177
View directory record Official record
Conditions
Hepatitis C Virus Infection
Interventions
Simeprevir, Sofosbuvir
Drug
Lead sponsor
Janssen Infectious Diseases BVBA
Industry
Eligibility
18 Years to 70 Years
Enrollment
310 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
38
States / cities
Dothan, Alabama • Bakersfield, California • Chula Vista, California + 35 more
Source: ClinicalTrials.gov public record
Updated Apr 11, 2016 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 2 Interventional Results available

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

NCT02262728
View directory record Official record
Conditions
Hepatitis C, Chronic
Interventions
Simeprevir, Daclatasvir, Sofosbuvir
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 3, 2025 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 2 Interventional Results available

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

NCT00882908
View directory record Official record
Conditions
Hepatitis C
Interventions
TMC435, Ribavirin (R), PegIFNα-2a (P), Placebo
Drug
Lead sponsor
Tibotec Pharmaceuticals, Ireland
Industry
Eligibility
18 Years to 70 Years
Enrollment
386 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
12
States / cities
Los Angeles, California • Jacksonville, Florida • Orlando, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Jun 15, 2014 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

NCT02885454
View directory record Official record
Conditions
Healthy
Interventions
Drospirenone/ethinylestradiol, AL-335, Odalasvir (ODV), Simeprevir (SMV)
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 22, 2017 · Synced Sep 3, 2026, 1:34 PM EDT
Withdrawn Phase 4 Interventional

Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

NCT02485080
View directory record Official record
Conditions
PT-NANBH
Interventions
Simeprevir, Sofosbuvir
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years to 72 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
2
States / cities
Palo Alto, California • New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 12, 2016 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 2 Interventional Results available

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

NCT01466790
View directory record Official record
Conditions
Hepatitis C
Interventions
TMC435, PSI-7977 (GS7977), Ribavirin
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years to 70 Years
Enrollment
168 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
22
States / cities
Hoover, Alabama • Bakersfield, California • La Jolla, California + 19 more
Source: ClinicalTrials.gov public record
Updated Feb 8, 2015 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 2 Interventional Results available

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

NCT01628692
View directory record Official record
Conditions
Hepatitis C Virus
Interventions
Daclatasvir, Simeprevir, Ribavirin
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years and older
Enrollment
230 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
7
States / cities
San Francisco, California • Indianapolis, Indiana • Lutherville, Maryland + 3 more
Source: ClinicalTrials.gov public record
Updated Feb 22, 2017 · Synced Sep 3, 2026, 1:34 PM EDT
Terminated Phase 3 Interventional Results available

Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis

NCT02455167
View directory record Official record
Conditions
Hepatitis C
Interventions
Simeprivir (SMV), Sofosbuvir (SOF), Ribavirin (RBV)
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 80 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Denver, Colorado
Source: ClinicalTrials.gov public record
Updated Sep 12, 2021 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 4 Interventional Results available

The SIM-SOF Trial for Hepatitis C

NCT02168361
View directory record Official record
Conditions
Chronic Hepatitis C
Interventions
Pegylated Interferon alfa-2b, Simeprevir, Ribavirin, Sofosbuvir
Drug
Lead sponsor
Center For Hepatitis C, Atlanta, GA
Other
Eligibility
18 Years and older
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Mar 13, 2016 · Synced Sep 3, 2026, 1:34 PM EDT
Withdrawn Phase 4 Interventional

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

NCT02206932
View directory record Official record
Conditions
Hepatitis C, Chronic, HIV CDC Category A1
Interventions
Sofosbuvir + Simeprevir
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jun 12, 2019 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01689623
View directory record Official record
Conditions
Healthy Participants
Interventions
TMC435, Atorvastatin, Simvastatin
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
19 Years to 55 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Mar 3, 2013 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01046058
View directory record Official record
Conditions
Hepatitis C Virus
Interventions
TMC435
Drug
Lead sponsor
Tibotec Pharmaceuticals, Ireland
Industry
Eligibility
18 Years to 65 Years
Enrollment
23 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2011
U.S. locations
3
States / cities
Anaheim, California • Orlando, Florida • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Oct 13, 2013 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01485991
View directory record Official record
Conditions
Hepatitis C
Interventions
TMC435, TVR
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years to 70 Years
Enrollment
771 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
32
States / cities
Bakersfield, California • San Diego, California • Aurora, Colorado + 29 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2016 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01289782
View directory record Official record
Conditions
Hepatitis C
Interventions
Placebo, TMC435, Peginterferon alpha-2a (PegIFN alpha-2a), Ribavirin (RBV)
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years and older
Enrollment
395 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
22
States / cities
Dothan, Alabama • Hoover, Alabama • Phoenix, Arizona + 19 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2014 · Synced Sep 3, 2026, 1:34 PM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)

NCT03059303
View directory record Official record
Conditions
Healthy
Interventions
Simeprevir 75 mg, Odalasvir 25 mg, Odalasvir 12.5 mg, Odalasvir 75 mg, AL-335 800 mg, Lansoprazole 30 mg, Omeprazole 20 mg
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 55 Years
Enrollment
72 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Dec 21, 2017 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 4 Interventional Results available

SMV + SOF With/Without RBV for IFN-II Patients With CHC

NCT02214420
View directory record Official record
Conditions
Hepatitis C
Interventions
Simeprevir, Sofosbuvir, Ribavirin
Drug
Lead sponsor
SC Liver Research Consortium, LLC
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
3
States / cities
La Jolla, California • New York, New York • Murray, Utah
Source: ClinicalTrials.gov public record
Updated Jun 18, 2018 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

NCT02114151
View directory record Official record
Conditions
Hepatitis C Virus Infection
Interventions
Simeprevir, Sofosbuvir
Drug
Lead sponsor
Janssen Infectious Diseases BVBA
Industry
Eligibility
18 Years to 70 Years
Enrollment
103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
32
States / cities
Dothan, Alabama • Bakersfield, California • Chula Vista, California + 29 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2016 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 2 Interventional Results available

Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

NCT02349048
View directory record Official record
Conditions
Hepatitis C Virus
Interventions
Simeprevir 150 mg, Daclatasvir 60 mg, Sofosbuvir 400 mg
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 70 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
7
States / cities
Bakersfield, California • Jacksonville, Florida • Lutherville, Maryland + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 28, 2017 · Synced Sep 3, 2026, 1:34 PM EDT
Terminated No phase listed Observational Results available

A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

NCT02292706
View directory record Official record
Conditions
Hepatitis C Virus Infection
Interventions
Sofosbuvir, Ribavirin, LDV/SOF, SOF/VEL, SOF/VEL/VOX, Other SOF-Based Regimen, Ineligible parent treatment
Drug · Other
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
1,609 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2021
U.S. locations
77
States / cities
Birmingham, Alabama • La Jolla, California • Long Beach, California + 57 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2023 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01479868
View directory record Official record
Conditions
Hepatitis C Virus Genotype-1
Interventions
TMC435, Pegylated interferon alpha-2a, Ribavirin
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years to 70 Years
Enrollment
109 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
10
States / cities
Los Angeles, California • Washington D.C., District of Columbia • Orlando, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 28, 2014 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 2 Interventional Results available

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

NCT00980330
View directory record Official record
Conditions
Hepatitis C
Interventions
TMC435, Placebo, Peg-IFN-alfa-2a (P), Ribavirin (R)
Drug
Lead sponsor
Tibotec Pharmaceuticals, Ireland
Industry
Eligibility
18 Years to 70 Years
Enrollment
463 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
17
States / cities
La Jolla, California • Los Angeles, California • Jacksonville, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2014 · Synced Sep 3, 2026, 1:34 PM EDT
Completed Phase 3 Interventional Results available

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

NCT01290679
View directory record Official record
Conditions
Hepatitis C
Interventions
Placebo, TMC435, Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Ribavirin (RBV)
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years and older
Enrollment
393 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
11
States / cities
Los Angeles, California • Jacksonville, Florida • Orlando, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 12, 2014 · Synced Sep 3, 2026, 1:34 PM EDT