Asunaprevir

Generic Name
Asunaprevir
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C35H46ClN5O9S
CAS Number
630420-16-5
Unique Ingredient Identifier
S9X0KRJ00S
Background

Asunaprevir, also named BMS-650032, is a potent hepatitis C virus (HCV) NS3 protease inhibitor. It has been shown to have a very high efficacy in dual-combination regimens with daclatasvir in patients chronically infected with HCV genotype 1b. It was developed by Bristol-Myers Squibb Canada and approved by Health Canada on April 22, 2016. The commercializati...

Indication

Asunaprevir is indicated in combination with other agents for the treatment of chronic hepatitis C in adult patients with hepatitis C virus genotypes 1 or 4 and compensated liver cirrhosis.
...

Associated Conditions
Chronic Hepatitis C Genotype 1, Genotype 4 Chronic Hepatitis C
Associated Therapies
-

Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV

First Posted Date
2016-12-29
Last Posted Date
2019-01-09
Lead Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Target Recruit Count
70
Registration Number
NCT03004625
Locations
🇨🇳

Kaohsiung Medical Universsity, Kaohsiung, Taiwan

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-07-14
Last Posted Date
2017-04-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
207
Registration Number
NCT02496078
Locations
🇷🇺

Local Institution, St.petersburg, Russian Federation

A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-12-23
Last Posted Date
2015-02-24
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
88
Registration Number
NCT02323594

Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-11-04
Last Posted Date
2015-10-19
Lead Sponsor
Foundation for Liver Research
Target Recruit Count
12
Registration Number
NCT02282709
Locations
🇳🇱

Erasmus Medical Center, Rotterdam, Netherlands

UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

First Posted Date
2014-04-25
Last Posted Date
2015-09-18
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
297
Registration Number
NCT02123654
Locations
🇯🇵

Local Institution, Saga, Japan

Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

First Posted Date
2014-04-08
Last Posted Date
2017-01-24
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
60
Registration Number
NCT02107365
Locations
🇫🇷

Hôpital Jean Verdier, Bondy, France

🇫🇷

Hôpital de Haut Lévêque, Bordeaux Pessac, France

🇫🇷

Hôpital Beaujon, Clichy, France

and more 22 locations

Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-11-26
Last Posted Date
2020-08-11
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
218
Registration Number
NCT01995266
Locations
🇨🇳

Local Institution, Tainan, Taiwan

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

First Posted Date
2013-10-31
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
202
Registration Number
NCT01973049
Locations
🇺🇸

Scripps Clinic, La Jolla, California, United States

🇺🇸

Binghamton Gastroenterology Associates, Binghamton, New York, United States

🇺🇸

Weill Cornell Medical College, New York, New York, United States

and more 24 locations

Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-06-26
Last Posted Date
2013-11-11
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
48
Registration Number
NCT01886599
Locations
🇺🇸

Davita Clinical Research, Minneapolis, Minnesota, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

New Orleans Center For Clinical Research, Knoxville, Tennessee, United States

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

First Posted Date
2012-10-31
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
258
Registration Number
NCT01718145
Locations
🇯🇵

Local Institution, Saitama, Japan

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