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
- -
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)
- Conditions
- Interventions
- 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
EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
- Conditions
- First Posted Date
- 2014-03-27
- Last Posted Date
- 2016-01-27
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT02097966
- Locations
- 🇬🇧
Local Institution, Wrexham, United Kingdom
🇬🇧Local Instituition, Liverpool, Merseyside, United Kingdom
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
- First Posted Date
- 2014-01-10
- Last Posted Date
- 2015-10-01
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 173
- Registration Number
- NCT02032901
- Locations
- 🇺🇸
Scripps Clinic, La Jolla, California, United States
🇺🇸University of Florida Hepatology Research, Gainesville, Florida, United States
🇺🇸Midland Florida Clinical Research Center, LLC, Deland, Florida, United States
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
- First Posted Date
- 2014-01-10
- Last Posted Date
- 2015-10-27
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 238
- Registration Number
- NCT02032888
- Locations
- 🇺🇸
University Gastroenterology, Providence, Rhode Island, United States
🇺🇸Lehigh Valley Health Network, Allentown, Pennsylvania, United States
🇺🇸Tarrant County Inf Dis Assoc, Fort Worth, Texas, United States
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant
- First Posted Date
- 2014-01-10
- Last Posted Date
- 2017-02-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 116
- Registration Number
- NCT02032875
- Locations
- 🇺🇸
University Of Miami Schiff Center For Liver Diseases, Miami, Florida, United States
🇺🇸University Of Michigan Health System, Ann Arbor, Michigan, United States
🇺🇸Baylor St. Luke'S Medical Center, Houston, Texas, United States
Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
- 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
- Conditions
- Interventions
- 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
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
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
- Conditions
- Interventions
- First Posted Date
- 2013-04-29
- Last Posted Date
- 2015-12-29
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 23
- Registration Number
- NCT01842451
- Locations
- 🇳🇿
New Zealand, Christchurch, New Zealand
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
- First Posted Date
- 2013-04-12
- Last Posted Date
- 2015-11-16
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 58
- Registration Number
- NCT01830205
- Locations
- 🇺🇸
Davita Clinical Research, Minneapolis, Minnesota, United States
🇺🇸Orlando Clinical Research Center, Orlando, Florida, United States
Drug Development Updates
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