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
- -
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
- First Posted Date
- 2016-12-14
- Last Posted Date
- 2023-08-25
- Lead Sponsor
- Tanta University
- Target Recruit Count
- 10000
- Registration Number
- NCT02992457
- Locations
- 🇪🇬
Tanta university hospital, Tanta, Egypt
🇪🇬Sherief Abd-Elsalam, Tanta, Egypt
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
- First Posted Date
- 2016-05-13
- Last Posted Date
- 2016-05-13
- Target Recruit Count
- 150
- Registration Number
- NCT02771405
- Locations
- 🇪🇬
Amr Maged, Cairo, Egypt
Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
- First Posted Date
- 2016-02-05
- Last Posted Date
- 2016-02-05
- Lead Sponsor
- Genuine Research Center, Egypt
- Target Recruit Count
- 24
- Registration Number
- NCT02675127
- Locations
- 🇪🇬
Genuine Research Center GRC, Cairo, Egypt
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
- Conditions
- Interventions
- First Posted Date
- 2015-12-28
- Last Posted Date
- 2021-07-30
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 506
- Registration Number
- NCT02640157
Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics
- Conditions
- Interventions
- First Posted Date
- 2015-11-04
- Last Posted Date
- 2023-04-20
- Lead Sponsor
- Tehran University of Medical Sciences
- Target Recruit Count
- 100
- Registration Number
- NCT02596880
- Locations
- 🇮🇷
Shariati Hospital, Tehran, Iran, Islamic Republic of
A Drug-drug Interaction Study Between Daclatasvir and Metformin
- Conditions
- Interventions
- First Posted Date
- 2015-10-01
- Last Posted Date
- 2020-12-07
- Lead Sponsor
- Radboud University Medical Center
- Target Recruit Count
- 20
- Registration Number
- NCT02565862
- Locations
- 🇳🇱
CRCN, Radboud University Medical Center, Nijmegen, Netherlands
A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat
- Conditions
- Interventions
- First Posted Date
- 2015-10-01
- Last Posted Date
- 2020-12-07
- Lead Sponsor
- Radboud University Medical Center
- Target Recruit Count
- 16
- Registration Number
- NCT02565888
- Locations
- 🇳🇱
CRCN, Radboud University Medical Center, Nijmegen, Netherlands
A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
- First Posted Date
- 2015-09-22
- Last Posted Date
- 2016-01-20
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT02556086
- Locations
- 🇫🇷
Local Institution, Pessac, France
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
- First Posted Date
- 2015-09-16
- Last Posted Date
- 2016-01-15
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT02551861
- Locations
- 🇫🇷
Local Institution, Vandoeuvre Les Nancy, France
A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
- 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
Drug Development Updates
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