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ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:54 AM EDT

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Showing 1–24 of 33 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: TMC435 Clear all
Completed Phase 3 Interventional Results available

3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection

NCT01349465
View directory record Official record
Conditions
Hepatitis C
Interventions
No treatment
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years and older
Enrollment
249 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
12
States / cities
Bakersfield, California • La Jolla, California • Los Angeles, California + 9 more
Source: ClinicalTrials.gov public record
Updated Apr 10, 2017 · Synced Oct 17, 2026, 6:54 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants

NCT03155893
View directory record Official record
Conditions
Healthy
Interventions
ODV Placebo (Matching 25 mg ODV), ODV Placebo (Matching 200 mg ODV), ODV Placebo (Matching 125 mg ODV), ODV Placebo (Matching 100 mg ODV), SMV Placebo (Matching 150 mg SMV), AL-335 Placebo (matching 1200 mg AL-335), Moxifloxacin Placebo (matching 400 mg moxifloxacin), ODV 25 mg, ODV 200 mg, ODV 125 mg, ODV 100 mg, SMV 150 mg, AL-335 1200 mg
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 55 Years
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Nov 14, 2017 · Synced Oct 17, 2026, 6:54 AM 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 9, 2015 · Synced Oct 17, 2026, 6:54 AM 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 26, 2016 · Synced Oct 17, 2026, 6:54 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT02018536
View directory record Official record
Conditions
Healthy
Interventions
GSK2336805 30 mg, GSK2336805 60 mg, GSK2336805 120 mg, TMC435 150 mg (Treatment A), GSK2336805 60 mg (Treatment B and part of Treatment C and D), TMC435 100 mg (part of Treatment C), TMC435 150 mg (part of treatment D)
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
20 Years to 55 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Cypress, California
Source: ClinicalTrials.gov public record
Updated Jun 17, 2014 · Synced Oct 17, 2026, 6:54 AM 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 29, 2014 · Synced Oct 17, 2026, 6:54 AM 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 Mar 1, 2017 · Synced Oct 17, 2026, 6:54 AM 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 13, 2021 · Synced Oct 17, 2026, 6:54 AM 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 13, 2016 · Synced Oct 17, 2026, 6:54 AM 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 22, 2017 · Synced Oct 17, 2026, 6:54 AM 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 13, 2014 · Synced Oct 17, 2026, 6:54 AM 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 19, 2018 · Synced Oct 17, 2026, 6:54 AM 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 12, 2016 · Synced Oct 17, 2026, 6:54 AM 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 4, 2023 · Synced Oct 17, 2026, 6:54 AM 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 24, 2016 · Synced Oct 17, 2026, 6:54 AM EDT
Completed Phase 3 Interventional Results available

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

NCT01281839
View directory record Official record
Conditions
Hepatitis C
Interventions
TMC435, Placebo, Peginterferon alpha-2a (PegIFN alpha-2a), Ribavirin (RBV)
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years and older
Enrollment
394 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
11
States / cities
Bakersfield, California • Aurora, Colorado • Jacksonville, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 23, 2014 · Synced Oct 17, 2026, 6:54 AM 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 4, 2013 · Synced Oct 17, 2026, 6:54 AM 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 14, 2013 · Synced Oct 17, 2026, 6:54 AM 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 13, 2019 · Synced Oct 17, 2026, 6:54 AM EDT
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 11, 2016 · Synced Oct 17, 2026, 6:54 AM 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 9, 2014 · Synced Oct 17, 2026, 6:54 AM 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 4, 2016 · Synced Oct 17, 2026, 6:54 AM 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 16, 2014 · Synced Oct 17, 2026, 6:54 AM 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 23, 2017 · Synced Oct 17, 2026, 6:54 AM EDT