Success Metrics

Clinical Success Rate
95.7%

Based on 22 completed trials

Completion Rate
96%(22/23)
Active Trials
0(0%)
Results Posted
55%(12 trials)
Terminated
1(4%)

Phase Distribution

Ph phase_2
9
38%
Ph phase_1
3
13%
Ph phase_3
4
17%
Ph phase_4
4
17%
Ph not_applicable
2
8%

Phase Distribution

3

Early Stage

9

Mid Stage

8

Late Stage

Phase Distribution22 total trials
Phase 1Safety & dosage
3(13.6%)
Phase 2Efficacy & side effects
9(40.9%)
Phase 3Large-scale testing
4(18.2%)
Phase 4Post-market surveillance
4(18.2%)
N/ANon-phased studies
2(9.1%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

91.7%

22 of 24 finished

Non-Completion Rate

8.3%

2 ended early

Currently Active

0

trials recruiting

Total Trials

24

all time

Status Distribution
Completed(22)
Terminated(2)

Detailed Status

Completed22
Terminated1
Withdrawn1

Development Timeline

Analytics

Development Status

Total Trials
24
Active
0
Success Rate
95.7%
Most Advanced
Phase 4

Trials by Phase

Phase 13 (13.6%)
Phase 29 (40.9%)
Phase 34 (18.2%)
Phase 44 (18.2%)
N/A2 (9.1%)

Trials by Status

completed2292%
terminated14%
withdrawn14%

Recent Activity

Clinical Trials (24)

Showing 20 of 24 trialsScroll for more
NCT02771405Phase 3

Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Completed
NCT02262728Phase 2

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

Completed
NCT02992457Phase 4

Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Completed
NCT02333292

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

Completed
NCT02404805Not Applicable

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers

Completed
NCT02765490Phase 2

Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

Completed
NCT02512562Phase 1

A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers

Completed
NCT03549832Not Applicable

Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Completed
NCT01938625Phase 2

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 Transplantation

Completed
NCT02214420Phase 4

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

Completed
NCT02268864Phase 2

A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants

Completed
NCT01628692Phase 2

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

Completed
NCT02118597

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

Terminated
NCT02250807Phase 3

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Completed
NCT02165189Phase 2

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

Completed
NCT02278419Phase 2

An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection

Completed
NCT02485080Phase 4

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

Withdrawn
NCT02114177Phase 3

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

Completed
NCT02114151Phase 3

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

Completed
NCT02168361Phase 4

The SIM-SOF Trial for Hepatitis C

Completed

Drug Details

Intervention Type
DRUG
Total Trials
24