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
- -
SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients
- Conditions
- Interventions
- First Posted Date
- 2015-06-16
- Last Posted Date
- 2018-03-19
- Lead Sponsor
- Humanity and Health Research Centre
- Target Recruit Count
- 106
- Registration Number
- NCT02473211
- Locations
- 🇨🇳
Humanity and Health GI and Liver Centre, Hong Kong, Hong Kong, China
🇨🇳Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital, Beijing, Beijing, China
Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
- First Posted Date
- 2015-01-07
- Last Posted Date
- 2022-06-29
- Lead Sponsor
- Valme University Hospital
- Target Recruit Count
- 1128
- Registration Number
- NCT02333292
- Locations
- 🇪🇸
Valme University Hospital, Seville, Andalusia, Spain
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
- First Posted Date
- 2014-12-23
- Last Posted Date
- 2015-02-24
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 88
- Registration Number
- NCT02323594
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
- First Posted Date
- 2014-12-18
- Last Posted Date
- 2017-01-27
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 53
- Registration Number
- NCT02319031
- Locations
- 🇫🇷
Local Institution, Vandoeuvre Les Nancy, France
Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics
- Conditions
- Interventions
- First Posted Date
- 2014-12-01
- Last Posted Date
- 2019-04-24
- Lead Sponsor
- Tarek I. Hassanein, M.D., FACP, FAG, AGAF
- Target Recruit Count
- 39
- Registration Number
- NCT02304159
- Locations
- 🇺🇸
Southern California Research Center, Coronado, California, United States
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
- 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
A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants
- First Posted Date
- 2014-10-20
- Last Posted Date
- 2017-03-16
- Lead Sponsor
- Janssen-Cilag International NV
- Target Recruit Count
- 106
- Registration Number
- NCT02268864
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
- Conditions
- Interventions
- First Posted Date
- 2014-10-13
- Last Posted Date
- 2019-05-08
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 40
- Registration Number
- NCT02262728
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
- Conditions
- Interventions
- First Posted Date
- 2014-06-09
- Last Posted Date
- 2015-11-30
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 49
- Registration Number
- NCT02159352
- Locations
- 🇺🇸
Healthcare Discoveries, Llc D/B/A Icon Development Solutions, San Antonio, Texas, United States
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
Drug Development Updates
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