Olysio (simeprevir) / Medivir, J&J  >>  Phase 3
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23 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Olysio (simeprevir) / J&J, Medivir
NCT01571570 / 2011-005808-14: A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.

Completed
3
72
Europe
TMC435 150 mg capsule, TMC435, TMC435 150 mg oral suspension (20 mg/mL), TMC435 150 mg oral solution (10 mg/mL), TMC435 150 mg capsule concept K, TMC435 150 mg capsule concept L
Janssen R&D Ireland
Healthy Volunteers
05/12
05/12
NCT01290731: A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

Checkmark CONCERTO-2 and CONCERTO-3
Mar 2014 - Mar 2014: CONCERTO-2 and CONCERTO-3
Checkmark APASL 2014: CONCERTO studies
Mar 2014 - Mar 2014: APASL 2014: CONCERTO studies
Checkmark CONCERTO studies
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Completed
3
49
Japan
TMC435, Pegylated interferon (pegIFN alpha-2a), PEGASYS, Ribavirin (RBV), COPEGUS
Janssen Pharmaceutical K.K.
Hepatitis C, Chronic
08/12
08/12
NCT01288209: A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy

Checkmark CONCERTO-2 and CONCERTO-3
Mar 2014 - Mar 2014: CONCERTO-2 and CONCERTO-3
Checkmark APASL 2014: CONCERTO studies
Mar 2014 - Mar 2014: APASL 2014: CONCERTO studies
Checkmark CONCERTO studies
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Completed
3
106
Japan
TMC435, Peginterferon alfa-2a (PegIFNα-2a ), PEGASYS, Ribavirin (RBV), COPEGUS
Janssen Pharmaceutical K.K.
Hepatitis C, Chronic
09/12
09/12
NCT01292239: A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

Checkmark CONCERTO-1
Apr 2014 - Apr 2014: CONCERTO-1
Checkmark APASL 2014: CONCERTO studies
Mar 2014 - Mar 2014: APASL 2014: CONCERTO studies
Checkmark CONCERTO studies
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Completed
3
183
Japan
Placebo, TMC435, Peginterferon alfa-2a (pegIFN alfa-2a), PEGASYS, Ribavirin (RBV), COPEGUS
Janssen Pharmaceutical K.K.
Hepatitis C, Chronic
10/12
10/12
NCT01366638: A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection

Checkmark CONCERTO-4
Jun 2014 - Jun 2014: CONCERTO-4
Checkmark APASL 2014: CONCERTO studies
Mar 2014 - Mar 2014: APASL 2014: CONCERTO studies
Checkmark CONCERTO studies
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Completed
3
79
Japan
TMC435, Peginterferon alfa-2b (pegIFN alfa-2b), PEGINTRON, Ribavirin (RBV), REBETOL
Janssen Pharmaceutical K.K.
Hepatitis C, Chronic
11/12
11/12
QUEST-1, NCT01289782 / 2010-020444-36: An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

Checkmark BWG 2015
Mar 2015 - Mar 2015: BWG 2015
Checkmark QUEST-1
Jun 2014 - Jun 2014: QUEST-1
Checkmark EASL 2014: QUEST 1 & QUEST 2
More
Completed
3
395
US, Canada, Europe, RoW
Placebo, TMC435, Peginterferon alpha-2a (PegIFN alpha-2a), Pegasys, Ribavirin (RBV), Copegus
Janssen R&D Ireland
Hepatitis C
01/13
01/13
PROMISE, NCT01281839 / 2010-021113-23: An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

Checkmark BWG 2015
Mar 2015 - Mar 2015: BWG 2015
Checkmark BWG 2014: PROMISE
Aug 2014 - Aug 2014: BWG 2014: PROMISE
Checkmark BWG 2014: PROMISE
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Completed
3
394
US, Canada, Europe, RoW
TMC435, Placebo, Peginterferon alpha-2a (PegIFN alpha-2a), Pegasys, Ribavirin (RBV), Copegus
Janssen R&D Ireland
Hepatitis C
02/13
02/13
QUEST-2, NCT01290679 / 2010-021174-11: An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

Checkmark BWG 2015
Mar 2015 - Mar 2015: BWG 2015
Checkmark QUEST-2
Jun 2014 - Jun 2014: QUEST-2
Checkmark EASL 2014: QUEST 1 & QUEST 2
More
Completed
3
393
US, Europe, RoW
Placebo, TMC435, Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), PegIFNα-2a (Pegasys), PegIFNα-2b (PegIntron), Ribavirin (RBV), Copegus, Rebetol
Janssen R&D Ireland
Hepatitis C
02/13
02/13
NCT01727323 / 2010-021337-31: 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

Active, not recruiting
3
109
US, Canada, Europe
TMC435, Pegylated interferon alpha-2a, Ribavirin
Janssen Research & Development, LLC, Janssen R&D Ireland, Tibotec Pharmaceuticals
Hepatitis C Virus Genotype-1
08/13
08/13
NCT01479868: 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

Checkmark
Sep 2014 - Sep 2014: 
Checkmark CROI 2014
Mar 2014 - Mar 2014: CROI 2014
Checkmark Primary results of naïve/relapser HIV/HCV co-infected patients at EACS
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Completed
3
109
US, Canada, Europe
TMC435, Pegylated interferon alpha-2a, Ribavirin
Janssen R&D Ireland
Hepatitis C Virus Genotype-1
08/13
08/13
RESTORE, NCT01567735 / 2011-004097-29: 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

Checkmark BWG 2015
Mar 2015 - Mar 2015: BWG 2015
Checkmark Presented at BWG 2015
Mar 2015 - Mar 2015: Presented at BWG 2015
Checkmark AASLD 2014: RESTORE
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Completed
3
107
Europe
TMC435
Janssen R&D Ireland
Hepatitis C
03/14
03/14
NCT01485991 / 2011-001180-53: 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

Checkmark BWG 2015
Mar 2015 - Mar 2015: BWG 2015
Checkmark VHC 2014: ATTAIN
Oct 2014 - Oct 2014: VHC 2014: ATTAIN
Checkmark ATTAIN
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Completed
3
771
US, Canada, Europe, RoW
TMC435, TVR
Janssen R&D Ireland
Hepatitis C
04/14
04/14
NCT01725529: An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

Checkmark From simeprevir + pegylated interferon alfa-2a + ribavirin trial in China for treatment naïve GT1 hep C infected patients
Mar 2015 - Mar 2015: From simeprevir + pegylated interferon alfa-2a + ribavirin trial in China for treatment naïve GT1 hep C infected patients
Completed
3
457
RoW
TMC435, Peginterferon-alpha (PegIFNα-2a), Ribavirin (RBV), Placebo
Janssen R&D Ireland
Hepatitis C, Chronic
08/14
11/14
NCT02114151: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

Checkmark AASLD 2015
Oct 2015 - Oct 2015: AASLD 2015
Checkmark From OPTIMIST-2 trial for chronic hep C infection at EASL 2015
Apr 2015 - Apr 2015: From OPTIMIST-2 trial for chronic hep C infection at EASL 2015
Completed
3
103
US, Canada
Simeprevir, Sofosbuvir
Janssen Infectious Diseases BVBA
Hepatitis C Virus Infection
01/15
04/15
NCT02114177: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

Checkmark HCV GT1 combo therapy (OPTIMIST-1)
Jan 2016 - Jan 2016: HCV GT1 combo therapy (OPTIMIST-1)
Checkmark From OPTIMIST-1 trial for chronic hep C infection at EASL 2015
Apr 2015 - Apr 2015: From OPTIMIST-1 trial for chronic hep C infection at EASL 2015
Completed
3
310
US, Canada
Simeprevir, Sofosbuvir
Janssen Infectious Diseases BVBA
Hepatitis C Virus Infection
01/15
04/15
NCT01323244 / 2011-000416-25: 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

Completed
3
142
US, Canada, Europe, RoW
TMC435
Janssen R&D Ireland
Hepatitis C
03/15
03/15
NCT01846832 / 2012-004905-29: A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

Checkmark Data from simeprevir + pegylated interferon alfa-2a + ribavirin 12-week triple combination, open-label, single-arm trial for treatment naïve GT1 hep C infected patients
Mar 2015 - Mar 2015: Data from simeprevir + pegylated interferon alfa-2a + ribavirin 12-week triple combination, open-label, single-arm trial for treatment naïve GT1 hep C infected patients
Completed
3
232
Europe, RoW
TMC435, Pegylated interferon alfa-2a (PegIFNα-2a), Pegasys, Ribavirin (RBV), Copegus
Janssen-Cilag International NV
Hepatitis C, Chronic, Infection
08/15
08/15
NCT02256176 / 2014-003446-27: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Not yet recruiting
3
40
Europe
Simeprevir, TMC435, Sofosbuvir
Janssen R&D Ireland, Janssen R&D Ireland
Chronic Hepatitis C, Genotype 4 Chronic Hepatitis C
11/15
01/16
NCT02250807: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Completed
3
40
Europe
Simeprevir, TMC435, Sofosbuvir
Janssen R&D Ireland
Chronic Hepatitis C, Genotype 4 Chronic Hepatitis C
12/15
12/15
NCT02455167: Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis

Terminated
3
9
US
Simeprivir (SMV), Olysio (Simeprivir);, Sofosbuvir (SOF), Solvaldi (Sofosbuvir);, Ribavirin (RBV), Virazole (Ribavirin);
University of Colorado, Denver, Janssen Scientific Affairs, LLC
Hepatitis C
07/16
07/16
NCT03099135 / 2016-002608-19: A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection

Terminated
3
24
Europe, Canada, RoW
No Treatment
Janssen Research & Development, LLC
Hepatitis C
02/18
02/18
FRI-STC, NCT02771405: Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Unknown status
3
150
RoW
Sofosbuvir, Sovaldi®, GS-7977, Ribavirin, Copegus®, Rebetol®, Simeprevir, Olysio®, TMC435, daclatasvir, clatazev®, BMS-790052, Ledipasvir, Co-formulated with Sofosbuvir in one tablet (Harvoni ® )
National Hepatology & Tropical Medicine Research Institute, Cairo University
Hepatitis C, Chronic, Hepatocellular Carcinoma
02/19
09/19
NCT05616598: Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Completed
2/3
200
RoW
Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Benha University
Male Infertility, HCV
11/22
12/22

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