84 completed, 3 terminated, 3 withdrawn, 2 unknown. 37 Phase 1, 24 Phase 2, 18 Phase 3, 7 Phase 4, 2 Not applicable.
By phase and status
Follow Simeprevir: new trials by email Literature Review of Simeprevir trials Research Report on Simeprevir
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure Sofosbuvir, Simeprevir, Daclatasvir - HCV Coinfection Not applicable Completed 40 2018-01-01 2019-03-19 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) Simeprevir 75 mg, Odalasvir 25 mg, Odalasvir 12.5 mg - Healthy Phase 1 Terminated 72 2017-02-20 2017-12-22 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-naive AL-335, Odalasvir (ODV), Simeprevir (SMV) - Hepatitis C, Chronic Phase 2 Completed 33 2016-12-21 2019-09-11 A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants Dabigatran etexilate mesylate, Odalasvir (ODV), Simeprevir (SMV) - Healthy Phase 1 Completed 15 2016-11-10 2025-02-03 Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection AL-335, Odalasvir, Simeprevir - Hepatitis C, Chronic Phase 2 Completed 365 2016-11-09 2019-11-20 To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants Drospirenone/ethinylestradiol, AL-335, Odalasvir (ODV) - Healthy Phase 1 Completed 24 2016-08-01 2017-01-23 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 Participants AL-335, Odalasvir (ODV), Simeprevir (SMV) - Healthy Phase 1 Completed 22 2016-05-01 2025-02-03 Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC Sofosbuvir, Ribavirin, Simeprevir - Hepatitis C, Chronic, Hepatocellular Carcinoma Phase 3 Completed 150 2016-03-01 2026-04-13 Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers dolutegravir, simeprevir - HIV, Hepatitis C Not applicable Completed 25 2016-02-01 2021-03-17 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) Daclatasvir + Sofosbuvir, Simeprevir + Sofosbuvir - Hepatitis C, Chronic Phase 4 Completed 121 2015-12-01 2017-08-01 A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir AL-335, Odalasvir (ODV), Simeprevir (SMV) - Chronic Hepatitis C Phase 2 Completed 161 2015-10-31 2019-07-16 Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1 Simeprevir, Sofosbuvir - PT-NANBH Phase 4 Withdrawn 2015-09-01 2016-10-13 A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers AL-335, ACH-3102, Simeprevir - Chronic Hepatitis C Phase 1 Completed 32 2015-07-31 2019-10-16 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 Infection Simeprevir (SMV), Ledipasvir (LDV), Sofosbuvir (SOF) - Hepatitis C, Chronic Phase 2 Completed 41 2015-05-19 2019-03-28 Switching Regimen in Treating Cirrhotic HCV GT1b Subjects PR4 + LDV/SOF + ASV 4 wk, PR4 + LDV/SOF + SMV 4 wk, PR4 + LDV/SOF + ASV 6 wk - Chronic Hepatitis C Infection Phase 2 Completed 138 2015-05-15 2025-03-26 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. Simeprevir (SMV) 150 mg, Daclatasvir (DCV) 60 mg - Renal Impairment, End-stage Renal Disease Phase 2 Withdrawn 2015-05-01 2015-07-17 Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis Simeprivir (SMV), Sofosbuvir (SOF), Ribavirin (RBV) - Hepatitis C Phase 3 Terminated 9 2015-05-01 2021-09-13 A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants Treatment A, Treatment B, Treatment C - Healthy Phase 1 Completed 48 2015-04-28 2017-09-07 Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients Sofosbuvir + Simeprevir + Ribavirin - Chronic Hepatitis C Virus Infection Phase 2 Completed 203 2015-04-01 2020-05-12 A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants Simeprevir, Daclatasvir - Hepatitis C, Chronic Phase 2 Completed 106 2015-01-01 2017-03-16
Showing 20 of 92. Sign in to see all of them.
Conditions studied Hepatitis C (54) · Hepatitis C, Chronic (27) · Fibrosis (4) · Acquired Immunodeficiency Syndrome (2) · Liver Cirrhosis (2) · Carcinoma, Hepatocellular (1) · Dermatitis, Phototoxic (1) · Infections (1) · Kidney Failure, Chronic (1) · Photosensitivity Disorders (1) · Renal Insufficiency (1) · Tuberculosis (1) · Virus Diseases (1)
Sponsors Tibotec Pharmaceuticals, Ireland (26) · Janssen R&D Ireland (17) · Janssen Research & Development, LLC (10) · Janssen Pharmaceutical K.K. (6) · Janssen-Cilag International NV (3) · Merck Sharp & Dohme LLC (3) · Alios Biopharma Inc. (2) · Humanity and Health Research Centre (2) · Janssen Infectious Diseases BVBA (2) · Janssen Sciences Ireland UC (2) · University of Colorado, Denver (2) · Valme University Hospital (2) · Arrowhead Regional Medical Center (1) · Assiut University (1) · Azienda Ospedaliera San Camillo Forlanini (1)
Countries United States (29) · Belgium (20) · Germany (17) · Spain (16) · France (14) · United Kingdom (14) · Canada (12) · Poland (9) · Austria (7) · Japan (7) · Puerto Rico (7) · Australia (6) · New Zealand (6) · Portugal (5) · Russia (5)
Top investigators Adriano M Pellicelli, MD (1) · Aisha El Sharkawy, MD (1) · Amanda Wieland, MD (1) · Amr Maged (1)
Results publications PMID 25445400 , PMID 25164700 , PMID 30853642 , PMID 37671831 , PMID 17593061 , PMID 17635375 , PMID 17850410 , PMID 18266997 , PMID 19053983 , PMID 19852962 , PMID 20951424 , PMID 22024518 , PMID 22885330 , PMID 23607594 , PMID 23907700 , PMID 24005956 , PMID 24184810 , PMID 24209977 , PMID 24602923 , PMID 24907224 , PMID 24907225 , PMID 24997638 , PMID 25078309 , PMID 25192745 , PMID 25482330 , PMID 25557952 , PMID 25596313 , PMID 26083155 , PMID 26453968 , PMID 26743093 , PMID 26753774 , PMID 26799692 , PMID 26890629 , PMID 27415157 , PMID 27428331 , PMID 27782373 , PMID 27790789 , PMID 27878906 , PMID 27882706 , PMID 27896822 , PMID 27896858 , PMID 27917405 , PMID 28004322 , PMID 28056030 , PMID 28135777 , PMID 28137633 , PMID 28295849 , PMID 28569206 , PMID 28577353 , PMID 28599618
NIH funding 2014 (4) , 2015 (2) , 2008 (1) , 2009 (1) , 2016 (1) , UL1TR001082 (1)