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.
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- 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
- -
Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
- Conditions
- Interventions
- First Posted Date
- 2013-02-25
- Last Posted Date
- 2013-11-25
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT01797848
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
- Conditions
- Interventions
- First Posted Date
- 2013-02-21
- Last Posted Date
- 2015-10-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 165
- Registration Number
- NCT01795911
- Locations
- 🇺🇸
Alamo Medical Research, San Antonio, Texas, United States
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
- Conditions
- Interventions
- First Posted Date
- 2012-12-05
- Last Posted Date
- 2020-08-11
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 71
- Registration Number
- NCT01741545
- Locations
- 🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇺🇸Hospital Of The University Of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸Stanford Boswell Clinic, Palo Alto, California, United States
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
- Conditions
- Interventions
- 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
Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy
- Conditions
- Interventions
- First Posted Date
- 2012-10-31
- Last Posted Date
- 2015-10-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 444
- Registration Number
- NCT01718158
- Locations
- 🇺🇸
Nashville Medical Research Institute, Nashville, Tennessee, United States
🇺🇸Va Long Beach Healthcare System, Long Beach, California, United States
🇬🇧Local Institution, London, Greater London, United Kingdom
Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
- Conditions
- Interventions
- First Posted Date
- 2012-06-28
- Last Posted Date
- 2014-05-09
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT01629732
- Locations
- 🇺🇸
Local Institution, Orlando, Florida, United States
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
- Conditions
- Interventions
- First Posted Date
- 2012-06-27
- Last Posted Date
- 2017-02-23
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 230
- Registration Number
- NCT01628692
- Locations
- 🇪🇸
Local Institution, Valencia, Spain
🇺🇸Johns Hopkins University, Lutherville, Maryland, United States
🇺🇸San Francisco General Hospital, San Francisco, California, United States
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
- First Posted Date
- 2012-06-11
- Last Posted Date
- 2015-10-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 880
- Registration Number
- NCT01616524
- Locations
- 🇺🇸
Precision Research Institute, Llc, San Diego, California, United States
🇺🇸Medical Associates Research Group, San Diego, California, United States
🇺🇸Orlando Infectious Disease Center, Orlando, Florida, United States
Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
- Conditions
- Interventions
- First Posted Date
- 2012-04-09
- Last Posted Date
- 2015-10-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 398
- Registration Number
- NCT01573351
- Locations
- 🇺🇸
University Of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸Gastro One, Germantown, Tennessee, United States
🇨🇳Local Institution, Taipei, Taiwan
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
- Conditions
- Interventions
- First Posted Date
- 2011-12-15
- Last Posted Date
- 2016-06-03
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 605
- Registration Number
- NCT01492426
- Locations
- 🇺🇸
The Kirklin Clinic, Birmingham, Alabama, United States
🇺🇸Atlanta Medical Center, Atlanta, Georgia, United States
🇺🇸Medical Associates Research Group, San Diego, California, United States
Drug Development Updates
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