Simeprevir
- Generic Name
- Simeprevir
- Brand Names
- -
- Drug Type
- Small Molecule
- Chemical Formula
- C38H47N5O7S2
- CAS Number
- 923604-59-5
- Unique Ingredient Identifier
- 9WS5RD66HZ
- Background
Simeprevir is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated in patient's with HCV genotype 1 for the treatment of chronic hepatitis C virus (HCV) infection. HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patie...
- Indication
Indicated for the treatment of adults with chronic hepatitis C virus (HCV) infection: typically in combination with sofosbuvir in patients with HCV genotype 1 without cirrhosis or with compensated cirrhosis and in combination with peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) in patients with HCV genotype 1 or 4 without cirrhosis or with compensated ...
- Associated Conditions
- Chronic Hepatitis C Genotype 1, Genotype 4 Chronic Hepatitis C
- Associated Therapies
- -
Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure
- Conditions
- Interventions
- First Posted Date
- 2018-06-08
- Last Posted Date
- 2019-03-19
- Lead Sponsor
- Assiut University
- Target Recruit Count
- 40
- Registration Number
- NCT03549832
- Locations
- 🇪🇬
Assiut University Hopsital, Assiut, Egypt
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
- First Posted Date
- 2016-12-14
- Last Posted Date
- 2023-08-25
- Lead Sponsor
- Tanta University
- Target Recruit Count
- 10000
- Registration Number
- NCT02992457
- Locations
- 🇪🇬
Tanta university hospital, Tanta, Egypt
🇪🇬Sherief Abd-Elsalam, Tanta, Egypt
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
- First Posted Date
- 2016-05-13
- Last Posted Date
- 2016-05-13
- Target Recruit Count
- 150
- Registration Number
- NCT02771405
- Locations
- 🇪🇬
Amr Maged, Cairo, Egypt
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
- Conditions
- Interventions
- First Posted Date
- 2016-05-06
- Last Posted Date
- 2019-11-20
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 365
- Registration Number
- NCT02765490
A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers
- Conditions
- Interventions
- First Posted Date
- 2015-07-31
- Last Posted Date
- 2019-10-16
- Lead Sponsor
- Alios Biopharma Inc.
- Target Recruit Count
- 32
- Registration Number
- NCT02512562
- Locations
- 🇫🇷
Biotrial, Rennes, France
Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1
- First Posted Date
- 2015-06-30
- Last Posted Date
- 2016-10-13
- Lead Sponsor
- Stanford University
- Registration Number
- NCT02485080
- Locations
- 🇺🇸
Stanford University Medical Center, Palo Alto, California, United States
🇺🇸Yale University Medical Center, New Haven, Connecticut, United States
Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers
- First Posted Date
- 2015-04-01
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 25
- Registration Number
- NCT02404805
- Locations
- 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
- First Posted Date
- 2015-01-07
- Last Posted Date
- 2022-06-29
- Lead Sponsor
- Valme University Hospital
- Target Recruit Count
- 1128
- Registration Number
- NCT02333292
- Locations
- 🇪🇸
Valme University Hospital, Seville, Andalusia, Spain
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
- First Posted Date
- 2014-10-30
- Last Posted Date
- 2016-10-14
- Lead Sponsor
- Janssen-Cilag International NV
- Target Recruit Count
- 63
- Registration Number
- NCT02278419
A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants
- First Posted Date
- 2014-10-20
- Last Posted Date
- 2017-03-16
- Lead Sponsor
- Janssen-Cilag International NV
- Target Recruit Count
- 106
- Registration Number
- NCT02268864
Drug Development Updates
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