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
- -
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
- Conditions
- Interventions
- First Posted Date
- 2014-10-13
- Last Posted Date
- 2019-05-08
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 40
- Registration Number
- NCT02262728
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
- First Posted Date
- 2014-10-01
- Last Posted Date
- 2016-02-24
- Lead Sponsor
- Peter J. Ruane, M.D.
- Target Recruit Count
- 30
- Registration Number
- NCT02253550
- Locations
- 🇺🇸
Peter J. Ruane, MD, Inc., Los Angeles, California, United States
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
- Conditions
- Interventions
- First Posted Date
- 2014-09-26
- Last Posted Date
- 2016-11-17
- Lead Sponsor
- Janssen R&D Ireland
- Target Recruit Count
- 40
- Registration Number
- NCT02250807
SMV + SOF With/Without RBV for IFN-II Patients With CHC
- First Posted Date
- 2014-08-12
- Last Posted Date
- 2018-06-19
- Lead Sponsor
- SC Liver Research Consortium, LLC
- Target Recruit Count
- 24
- Registration Number
- NCT02214420
- Locations
- 🇺🇸
Scripps Clinic, La Jolla, California, United States
🇺🇸Clinical Research Centers of America, LLC, Murray, Utah, United States
🇺🇸Icahn School of Medicine at Mt. Sinai, New York, New York, United States
The SIM-SOF Trial for Hepatitis C
- Conditions
- Interventions
- First Posted Date
- 2014-06-20
- Last Posted Date
- 2016-03-14
- Lead Sponsor
- Center For Hepatitis C, Atlanta, GA
- Target Recruit Count
- 93
- Registration Number
- NCT02168361
- Locations
- 🇺🇸
Center for Hepatitis C, Atlanta, Georgia, United States
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
- First Posted Date
- 2014-06-17
- Last Posted Date
- 2016-11-11
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- Target Recruit Count
- 46
- Registration Number
- NCT02165189
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
- Conditions
- Interventions
- First Posted Date
- 2014-04-21
- Last Posted Date
- 2016-12-12
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 19
- Registration Number
- NCT02118597
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
- First Posted Date
- 2014-04-15
- Last Posted Date
- 2016-04-12
- Lead Sponsor
- Janssen Infectious Diseases BVBA
- Target Recruit Count
- 310
- Registration Number
- NCT02114177
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
- First Posted Date
- 2014-04-15
- Last Posted Date
- 2016-04-04
- Lead Sponsor
- Janssen Infectious Diseases BVBA
- Target Recruit Count
- 103
- Registration Number
- NCT02114151
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
- Conditions
- Interventions
- First Posted Date
- 2013-09-10
- Last Posted Date
- 2018-11-21
- Lead Sponsor
- Janssen R&D Ireland
- Target Recruit Count
- 35
- Registration Number
- NCT01938625
Drug Development Updates
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