Drug
Simeprevir clinical trials
Also written TMC435, Olysio and TMC435350.
- studies test it
- 77
- open now
- 0
- in phase 3
- 18
- first study started
- 2007
How studies write it
Studies that test it under each name
Name
Brand
Studies by the year they started
77 studies that test it; most in 2011 (16)
| Year | Studies |
|---|---|
| 2007 | 1 |
| 2008 | 4 |
| 2009 | 6 |
| 2010 | 9 |
| 2011 | 16 |
| 2012 | 7 |
| 2013 | 5 |
| 2014 | 8 |
| 2015 | 12 |
| 2016 | 7 |
| 2018 | 1 |
| 2022 | 1 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 36
- Phase 2
- 17
- Phase 3
- 18
- Phase 4
- 5
- No phase
- 2
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 66 · Other 11
Tibotec Pharmaceuticals, Ireland (26) · Janssen R&D Ireland (14) · Janssen Research & Development, LLC (9) · Janssen Pharmaceutical K.K. (6) · Janssen-Cilag International NV (3) · Alios Biopharma Inc. (2) · Janssen Sciences Ireland UC (2) · Janssen Infectious Diseases BVBA (2)
Often tested with
Tested in the same studies.
Sofosbuvir (14) · Daclatasvir (9) · Ribavirin (9) · Odalasvir (6) · Adafosbuvir (5) · Ledipasvir (3) · Peginterferon alfa-2a (3) · Tmc-647055 (3)
Studies
Open first, then newest update. How each study uses Simeprevir is read from its arms, and is right about nine times in ten.
Testing it · 77
- Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCCCompletedPhase 3National Hepatology & Tropical Medicine Research InstituteNCT02771405Written as Simeprevir
- 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 DiseaseCompletedPhase 2Janssen Research & Development, LLCNCT02262728Written as Simeprevir
- A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy ParticipantsCompletedPhase 1Janssen Research & Development, LLCNCT02945020Written as Simeprevir (SMV)
- 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 ParticipantsCompletedPhase 1Janssen Research & Development, LLCNCT02824315Written as Simeprevir (SMV)
- Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C InfectionCompletedPhase 4Tanta UniversityNCT02992457Written as Simeprevir
- Effect of New Oral Treatment for Hepatitis C Virus on Seminal ParametersCompletedPhase 2/3Benha UniversityNCT05616598Written as Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
- Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative VolunteersCompletedNot applicableUniversity of Colorado, DenverNCT02404805Written as simeprevir
- Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian PatientsCompletedPhase 2Beni-Suef UniversityNCT04385407Written as Sofosbuvir + Simeprevir + Ribavirin
- Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C InfectionCompletedPhase 2Janssen Research & Development, LLCNCT02765490Written as Simeprevir
- A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy VolunteersCompletedPhase 1Alios Biopharma Inc.NCT02512562Written as Simeprevir
- 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-naiveCompletedPhase 2Janssen Pharmaceutical K.K.NCT02993250Written as Simeprevir (SMV)
- A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and SimeprevirCompletedPhase 2Alios Biopharma Inc.NCT02569710Written as Simeprevir (SMV)
- A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis CWithdrawnPhase 4University of California, San FranciscoNCT02206932Written as Sofosbuvir + Simeprevir
- 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 InfectionCompletedPhase 2Janssen Sciences Ireland UCNCT02421211Written as Simeprevir (SMV)
- Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir FailureCompletedNot applicableAssiut UniversityNCT03549832Written as Simeprevir
- A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult ParticipantsCompletedPhase 1Janssen Sciences Ireland UCNCT02385071Written as Treatment A
- 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)CompletedPhase 4Federal University of São PauloNCT02624063Written as Simeprevir + Sofosbuvir
- 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 PatientsCompletedPhase 3Janssen R&D IrelandNCT01567735Written as TMC435
- A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected ParticipantsCompletedPhase 2Janssen-Cilag International NVNCT02268864Written as Simeprevir
- Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 InfectionCompletedPhase 2Janssen Research & Development, LLCNCT02349048Written as Simeprevir 150 mg
See all 77 studies that test Simeprevir →
Given in every arm · 8 — Simeprevir is usual care beside what is tested
- A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver TransplantationCompletedPhase 2Janssen R&D IrelandNCT01938625Written as Simeprevir
- SMV + SOF With/Without RBV for IFN-II Patients With CHCCompletedPhase 4SC Liver Research Consortium, LLCNCT02214420Written as Simeprevir
- 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)TerminatedPhase 1Janssen Research & Development, LLCNCT03059303Written as Simeprevir 75 mg
- Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C VirusCompletedPhase 2Bristol-Myers SquibbNCT01628692Written as Simeprevir
- An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver TransplantCompletedPhase 2Janssen Scientific Affairs, LLCNCT02165189Written as Simeprevir
- A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C VirusCompletedPhase 2Janssen R&D IrelandNCT01724086Written as TMC435
- Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)CompletedPhase 2Merck Sharp & Dohme LLCNCT01852604Written as Simeprevir
- 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 PatientsCompletedPhase 2Janssen R&D IrelandNCT01466790Written as TMC435
Codes
What other systems call Simeprevir · ClinicalTrials.gg INT006621
- MeSH (NLM) D000069616SimeprevirConfirmed ClinicalTrials.gov, NLM, Wikidata
- UNII (FDA) 9WS5RD66HZSIMEPREVIRConfirmed FDA, NLM, Wikidata
- RxNorm 1482790Confirmed FDA, Wikidata
- Wikidata Q7517689simeprevirConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C129015SimeprevirOne source FDA
- DrugBank DB06290One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D000069616 | Simeprevir | Confirmed ClinicalTrials.gov, NLM, Wikidata |
| UNII (FDA) | 9WS5RD66HZ | SIMEPREVIR | Confirmed FDA, NLM, Wikidata |
| RxNorm | 1482790 | — | Confirmed FDA, Wikidata |
| Wikidata | Q7517689 | simeprevir | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C129015 | Simeprevir | One source FDA |
| DrugBank | DB06290 | — | One source Wikidata |
Also registered as simeprevir sodium (UNII 16U7H60184 · RxNorm 1484518).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.