Daclatasvir

Generic Name
Daclatasvir
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C40H50N8O6
CAS Number
1009119-64-5
Unique Ingredient Identifier
LI2427F9CI
Background

Daclatasvir is a direct-acting antiviral agent against Hepatitis C Virus (HCV) used for the treatment of chronic HCV genotype 1 and 3 infection. It is marketed under the name DAKLINZA and is contained in daily oral tablets as the hydrochloride salt form . Hepatitis C is an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a si...

Indication

Indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1a/b or 3 infection. The dosing regimen of 60mg daclatasvir 60 mg with 400mg sofosbuvir once a day is recommended for both genontypes.
...

Associated Conditions
Chronic Hepatitis C - Genotype 3, Chronic Hepatitis C Genotype 1, Chronic Hepatitis C Virus (HCV) Infection, Chronic hepatitis C genotype 2
Associated Therapies
-

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

First Posted Date
2009-11-20
Last Posted Date
2015-09-11
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
55
Registration Number
NCT01017575
Locations
🇯🇵

Local Institution, Musashino-Shi, Tokyo, Japan

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

First Posted Date
2009-11-20
Last Posted Date
2015-10-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
51
Registration Number
NCT01016912
Locations
🇯🇵

Local Institution, Minato-Ku, Tokyo, Japan

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

First Posted Date
2009-11-13
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
215
Registration Number
NCT01012895
Locations
🇺🇸

Advanced Clinical Research Institute, Anaheim, California, United States

🇺🇸

Mercy Medical Center, Baltimore, Maryland, United States

🇺🇸

Carolinas Center For Liver Disease, Statesville, North Carolina, United States

and more 8 locations

Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects

First Posted Date
2009-09-24
Last Posted Date
2015-10-16
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
47
Registration Number
NCT00983957
Locations
🇺🇸

MDS Pharma Services (US), Inc, Tempe, Arizona, United States

🇺🇸

Covance Clinical Research Unit, Inc., Austin, Texas, United States

🇨🇦

Local Institution, St. Laurent, Quebec, Canada

Drug-Drug Interaction Study in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-05-19
Last Posted Date
2011-01-07
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
28
Registration Number
NCT00904059
Locations
🇺🇸

Ppd Development, Lp, Austin, Texas, United States

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

First Posted Date
2009-04-03
Last Posted Date
2015-10-23
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
74
Registration Number
NCT00874770
Locations
🇺🇸

Alabama Liver & Digestive Specialists (Alds), Montgomery, Alabama, United States

🇺🇸

Llc Dba The Research Institute, Springfield, Massachusetts, United States

🇺🇸

Veterans Affairs Medical Center, Bronx, New York, United States

and more 9 locations

Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-03-10
Last Posted Date
2015-10-08
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
46
Registration Number
NCT00859053
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

Advanced Clinical Research Institute, Anaheim, California, United States

A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-04-22
Last Posted Date
2015-10-14
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
167
Registration Number
NCT00663208
Locations
🇺🇸

West Coast Clinical Trials, Llc, Cypress, California, United States

🇵🇷

Local Institution, Santurce, Puerto Rico

🇺🇸

Advanced Clinical Res Inst, Anaheim, California, United States

and more 5 locations

A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2007-10-19
Last Posted Date
2015-11-18
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
95
Registration Number
NCT00546715
Locations
🇺🇸

Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey, United States

🇺🇸

Advanced Clinical Research Institute, Anaheim, California, United States

🇺🇸

University Of Virginia Digestive Health Center Of Excellence, Charlottesville, Virginia, United States

and more 4 locations
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