Daclatasvir Dihydrochloride
Beskriuwing
Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) is in krêftich en oraal aktyfHCV NS5A proteïneinhibitor meiEC50s berik fan 9-146 pm foarmeardere HCV-replikongenotypen.Daclatasvir dihydrochloride is ek inorganysk anion ferfierend polypeptide 1B (OATP1B)enOATP1B3inhibitor meiIC50s fan respektivelik 1,5 µM en 3,27 µM.
IC50& Doel
EC50: 50 pM (HCV-replikon genotyp 1a), 9 pM (HCV-replikon genotyp 1b), 71 pM (HCV-replikon genotype 2a), 146 pM (HCV-replikon genotype 3a), 12 pM (HCV-replikon genotype 33 pM en 4a) HCV-replikon genotyp 5a)[1]
Kd: 8 nM (NS5A33-202) en 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) en 3.27 µM (OATP1B3)[3]
In vitro
Daclatasvir (BMS-790052) toant krêftige remmende aktiviteit foar alle geteste genotypen, mei EC50wearden fariearjend fan 9 pm oant 146 pm.Daclatasvir inhibeart HCV-replikon genotyp 1a, 1b, 2a, 3a, 4a en 5a mei EC50wearden fan respektivelik 50 pM, 9 pM, 71 pM, 146 pM, 12 pM en 33 pM.Daclatasvir is in krêftige ynhibitor fan it JFH-1 genotype 2a ynfekteare firus dat replikearret yn selkultuer (EC)50= 28 oere)[1].Daclatasvir (BMS-790052) bindet strak oan NS5A33-202 en NS5A26-202 mei Kds fan respektivelik 8 nM en 210 nM[2].
Opslach
| Poeder | -20°C | 3 jier |
| 4°C | 2 jier | |
| Yn oplosmiddel | -80°C | 6 moanne |
| -20°C | 1 moanne |
Klinyske test
| NCT nûmer | Sponsor | Betingst | Begjin Datum | Faze |
| NCT03369327 | Teheran University of Medical Sciences|RojanPharma Pharmaceutical Company | Hepatitis C firusynfeksje, antwurd op terapy fan | Human Immunodeficiency Virus | 1 jannewaris 2017 | Fase 3 |
| NCT03485846 | R-Pharm|Almedis | Chronische hepatitis C genotyp 1b | 27 novimber 2017 | Fase 2 |
| NCT01016912 | Bristol-Myers Squibb | Hepatitis C ynfeksje | desimber 2009 | Fase 2 |
| NCT01629732 | Bristol-Myers Squibb | Hepatitis C firus | maart 2013 | Fase 2 |
| NCT01497834 | Bristol-Myers Squibb | Hepatitis C | Jannewaris 2012 | Fase 3 |
| NCT01973049 | Bristol-Myers Squibb | Hepatitis C | desimber 2013 | Fase 3 |
| NCT00663208 | Bristol-Myers Squibb | Chronyske hepatitis C | Mei 2008 | Fase 2 |
| NCT02576314 | Humanity and Health Research Centre|Beijing 302 Hospital | Chronyske hepatitis C-ynfeksje | Mei 2015 | Fase 3 |
| NCT02756936 | Genuine Research Center, Egypte | Zeta Pharma Pharmaceutical Industries | Sûn | febrewaris 2016 | Fase 1 |
| NCT02771405 | National Hepatology & Tropical Medicine Research Institute | Cairo University | Hepatitis C, Chronic | Hepatocellular Carcinoma | maart 2016 | Fase 3 |
| NCT03706898 | Viriom | HIV-1-ynfeksje|Hepatyske beheining | 1 oktober 2018 | Fase 1 |
| NCT02319031 | Bristol-Myers Squibb | Hepatitis C | febrewaris 2015 | Fase 3 |
| NCT02124044 | National Institutes of Health Clinical Center (CC) | Nasjonaal Ynstitút foar Allergy en ynfeksjesykten (NIAID) | Bristol-Myers Squibb | HIV-HCV | febrewaris 2014 | Fase 2 |
| NCT02551861 | Bristol-Myers Squibb | Hepatitis C | desimber 2015 | Fase 2 |
| NCT00859053 | Bristol-Myers Squibb | Hepatyske ynsuffisjinsje | maart 2009 | Fase 1 |
| NCT01257204 | Bristol-Myers Squibb | Hepatitis C firus | desimber 2010 | Fase 2 |
| NCT03063879 | Teheran University of Medical Sciences|Ahvaz Jundishapur University of Medical Sciences|Shiraz University of Medical Sciences|Hamadan University of Medical Science | Hepatitis C, chronike | chronike renale mislearring | 1 april 2017 | Fase 4 |
| NCT01017575 | Bristol-Myers Squibb | Hepatitis C ynfeksje | desimber 2009 | Fase 2 |
| NCT02865369 | Sang Gyune Kim|Seoul National University Boramae Hospital|Severance Hospital|Inha University Hospital|Korea University|Gachon University Gil Medical Center|Hanyang University Seoul Hospital|Ewha Womans University Mokdong Hospital|Bristol-Myers Squibb|Soonchunhyang University Hospital | Chronyske hepatitis C | septimber 2016 |
|
| NCT04070235 | De skiednis fan Nanjing Sanhome Pharmaceutical, Co., Ltd. | Hepatitis C, chronike | 29 maart 2019 | Fase 2 | Fase 3 |
| NCT03487848 | Bristol-Myers Squibb | Hepatitis C | Chronyske hepatitis | 18 mei 2018 | Fase 2 |
| NCT00904059 | Bristol-Myers Squibb | Hepatitis C | Mei 2009 | Fase 1 |
| NCT02107365 | Frânsk Nasjonaal Ynstitút foar Sûnens en Medysk Undersyk-Frânsk Nasjonaal Agintskip foar Undersyk nei AIDS en Virale Hepatitis (Inserm-ANRS)|Bristol-Myers Squibb | Hepatitis C Virus Genotype 4 Ynfeksje | novimber 2013 | Fase 2 |
| NCT02397395 | Janssen R&D Ierlân | Nierfermindering|Nierensykte yn it einfaze | Mei 2015 | Fase 2 |
| NCT03169348 | Assiut University | Hepatitis C | 1 novimber 2017 | Net fan tapassing |
| NCT02323594 | Bristol-Myers Squibb | Hepatitis C ynfeksje | desimber 2014 | Fase 1 |
| NCT03537196 | Frânsk Nasjonaal Ynstitút foar Sûnens en Medysk Undersyk - Frânsk Nasjonaal Agintskip foar Undersyk nei AIDS en Virale Hepatitis (Inserm-ANRS) | Hepatitis C | Drugsgebrûk | Virale hepatitis C | 13 novimber 2018 | Fase 4 |
| NCT02103569 | Bristol-Myers Squibb | Hepatitis C | april 2014 | Fase 1 |
| NCT02772744 | Universiteit fan Zagazig | Universiteit fan Kairo | Hepatitis C | 1 novimber 2017 |
|
| NCT01718158 | Bristol-Myers Squibb | Hepatitis C | Jannewaris 2013 | Fase 3 |
| NCT02496078 | Bristol-Myers Squibb | Hepatitis C | augustus 2015 | Fase 3 |
| NCT01425970 | Bristol-Myers Squibb | Hepatitis C | Mei 2012 | Fase 2 |
| NCT01471574 | Bristol-Myers Squibb | Hepatitis C, Genotype 1 | desimber 2011 | Fase 3 |
| NCT01573351 | Bristol-Myers Squibb | Hepatitis C firus | Mei 2012 | Fase 3 |
| NCT01938625 | Janssen R&D Ierlân | Hepatitis C, chronike | 12 desimber 2013 | Fase 2 |
| NCT01492426 | Bristol-Myers Squibb | Hepatitis C | Jannewaris 2012 | Fase 3 |
| NCT03480932 | Johns Hopkins Bloomberg School of Public Health | Nasjonaal Ynstitút foar Drug Abuse (NIDA) | YR Gaitonde Sintrum foar AIDS Undersyk en Underwiis | Hepatitis C, chronike | 2 febrewaris 2018 | Fase 2 | Fase 3 |
| NCT03163849 | Assiut University | Chronyske hepatitis c | 1 septimber 2019 | Fase 3 |
| NCT01581203 | Bristol-Myers Squibb | Hepatitis C firus | Mei 2012 | Fase 3 |
| NCT01492504 | Bristol-Myers Squibb | Hepatitis C | 7 febrewaris 2012 |
|
| NCT03686722 | Mohamed Raslan|Ain Shams University|Drug Research Centre, Kairo, Egypte | Diabetes mellitus, Type 2 | Hepatitis C | Drug ynteraksjes | 9 septimber 2017 | Fase 1 |
| NCT02262728 | Janssen Research & Development, LLC | Hepatitis C, chronike | 30 septimber 2014 | Fase 2 |
| NCT02349048 | Janssen Research & Development, LLC | Hepatitis C firus | Jannewaris 2015 | Fase 2 |
| NCT03882307 | Assiut University | Hepatitis C, chronike | Mei 2020 | Iere faze 1 |
| NCT02758509 | Parc de Salut Mar | Chronyske hepatitis C | Cirrhosis | 1 jannewaris 2010 |
|
| NCT01795911 | Bristol-Myers Squibb | Hepatitis C | maart 2013 | Fase 2 |
| NCT03549832 | Assiut University | Sohag University | South Valley University | HCV Coinfection | 1 jannewaris 2018 | Net fan tapassing |
| NCT02161939 | Bristol-Myers Squibb | Chronyske hepatitis C |
| |
| NCT01309932 | Bristol-Myers Squibb | Hepatitis C | maart 2011 | Fase 2 |
| NCT01995266 | Bristol-Myers Squibb | Hepatitis C | 28 febrewaris 2014 | Fase 3 |
| NCT02640157 | AbbVie | Chronic Hepatitis C | Hepatitis C Virus | Genotype 3 Hepatitis C Virus | desimber 2015 | Fase 3 |
| NCT02032875 | Bristol-Myers Squibb | Hepatitis C | maart 2014 | Fase 3 |
| NCT02624063 | Federale Universiteit fan São Paulo | Hepatitis C, chronike | desimber 2015 | Fase 4 |
| NCT00546715 | Bristol-Myers Squibb | Chronyske hepatitis C | novimber 2007 | Fase 1 | Fase 2 |
| NCT01718145 | Bristol-Myers Squibb | Hepatitis C firus ynfeksje | novimber 2012 | Fase 3 |
| NCT01616524 | Bristol-Myers Squibb | Hepatitis C firus (HCV) | july 2012 | Fase 3 |
| NCT02032901 | Bristol-Myers Squibb | Hepatitis C | Jannewaris 2014 | Fase 3 |
| NCT03540212 | Ain Shams University | Chronyske HCV-ynfeksje | 10 desimber 2017 | Fase 2 | Fase 3 |
| NCT02097966 | Bristol-Myers Squibb | Chronyske hepatitis C |
| |
| NCT02596880 | Teheran Universiteit fan Medyske Wittenskippen | Hepatitis C | Cirrhosis | septimber 2015 | Fase 3 |
| NCT04019717 | De bedriuw Atea Pharmaceuticals, Inc. | Hepatitis C | Hepatitis C, chronike | Chronyske hepatitis C | Hepatitis C firusynfeksje | HCV-ynfeksje | 20 juny 2019 | Fase 2 |
| NCT02992457 | Tanta Universiteit | Hepatitis C | Jannewaris 2015 | Fase 4 |
| NCT03547895 | Zagazig Universiteit | Dekompensearre cirrhosis | 1 juny 2015 | Net fan tapassing |
| NCT03004625 | Kaohsiung Medical University Chung-Ho Memorial Hospital|Chang Gung Memorial Hospital|Nasjonaal Taiwan University Hospital|Taipei Veterans General Hospital, Taiwan|China Medical University Hospital|Nasjonaal Cheng-Kung University Hospital | Hepatitis C | novimber 2016 | Fase 3 |
| NCT01051414 | Bristol-Myers Squibb | Hepatitis C ynfeksje | april 2010 | Fase 2 |
| NCT02309450 | Frânsk Nasjonaal Ynstitút foar Sûnens en Medysk Undersyk-Frânsk Nasjonaal Agintskip foar Undersyk nei AIDS en Virale Hepatitis (Inserm-ANRS)|Bristol-Myers Squibb | Hepatitis C Virus Genotype 4 Ynfeksje | desimber 2014 | Fase 2 |
| NCT01628692 | Bristol-Myers Squibb|Janssen Research & Development, LLC | Hepatitis C firus | july 2012 | Fase 2 |
| NCT03186313 | Egyptysk lever sikehûs | Wadi El Nil sikehûs | Hepatitis C | septimber 2016 | Fase 3 |
| NCT03063723 | Tredde oansletten sikehûs, Sun Yat-Sen University | Chronyske hepatitis C (steurnis) | 1 jannewaris 2016 |
|
| NCT00983957 | Bristol-Myers Squibb | Chronyske hepatitis C | oktober 2009 | Fase 1 |
| NCT01725542 | Frânsk Nasjonaal Ynstitút foar Sûnens en Medysk Undersyk-Frânsk Nasjonaal Agintskip foar Undersyk nei AIDS en Virale Hepatitis (Inserm-ANRS)|Bristol-Myers Squibb | HCV-HIV Co-ynfeksje | desimber 2012 | Fase 2 |
| NCT02282709 | Stichting foar leverûndersyk | Chronyske hepatitis C | febrewaris 2014 | Fase 3 |
| NCT02032888 | Bristol-Myers Squibb | Hepatitis C | febrewaris 2014 | Fase 3 |
| NCT03247296 | MTI Universiteit | Hepatitis C | 28 febrewaris 2017 |
|
| NCT01389323 | Bristol-Myers Squibb | Hepatitis C | septimber 2011 | Fase 3 |
| NCT02556086 | Bristol-Myers Squibb | Hepatitis C | desimber 2015 | Fase 2 |
| NCT01741545 | Bristol-Myers Squibb | Hepatitis C firus | 31 maart 2013 | Fase 3 |
| NCT01866930 | Bristol-Myers Squibb | Chronyske hepatitis C-ynfeksje | 11 july 2013 | Fase 3 |
| NCT02268864 | Janssen-Cilag International NV | Hepatitis C, chronike | Jannewaris 2015 | Fase 2 |
| NCT01797848 | Bristol-Myers Squibb | Hepatitis C | juny 2014 | Fase 3 |
| NCT03166280 | Eman Sayed Hassan Abd Allah | Assiut University | Hepatitis C | juny 2017 |
|
| NCT02159352 | Bristol-Myers Squibb | Hepatitis C | juny 2014 | Fase 1 |
| NCT01125189 | Bristol-Myers Squibb | Hepatitis C firus | july 2010 | Fase 2 |
| NCT03748745 | De skiednis fan Nanjing Sanhome Pharmaceutical, Co., Ltd. | Drug ynteraksjes | 19 novimber 2018 | Fase 1 |
| NCT01012895 | Bristol-Myers Squibb | Chronyske hepatitis C | desimber 2009 | Fase 2 |
| NCT02565888 | Radboud Universiteit | Hepatitis C | HIV | novimber 2015 | Fase 1 |
| NCT02555943 | Humanity and Health Research Centre|Beijing 302 Hospital|Nanfang Hospital of Southern Medical University | Chronyske hepatitis C-ynfeksje|HBV-koinfeksje|Hepatitis B-reaktivaasje | febrewaris 2015 | Fase 2 | Fase 3 |
| NCT02304159 | Tarek I. Hassanein, MD, FACP, FAG, AGAF|Southern California Research Center | Hepatitis C | Cirrhosis | Jannewaris 2015 | Fase 4 |
| NCT02580474 | Myeong Jun Song|Bristol-Myers Squibb|Soonchunhyang University Hospital|Dankook University|Chungnam National University Hospital|Konyang University Hospital|Eulji University Hospital|Saint Vincent's Hospital, Korea|Konkuk University Hospital|Cheongju St. Mary's Hospital, Cheongju , Korea|Severance Hospital|Korea University Guro Hospital|Eulji Algemien sikehûs|De Katolike Universiteit fan Korea | Hepatitis C | febrewaris 2016 | Fase 4 |
| NCT02104843 | Bristol-Myers Squibb | Hepatitis C | april 2014 | Fase 1 |
| NCT01428063 | Bristol-Myers Squibb | Hepatitis C firus ynfeksje | septimber 2011 | Fase 2 |
| NCT02123654 | Bristol-Myers Squibb | Hepatitis C firus ynfeksje | april 2014 | Fase 3 |
| NCT02565862 | Radboud Universiteit | Hepatitis C | Diabetes Mellitus | Ynsulineresistinsje | Jannewaris 2016 | Fase 1 |
| NCT04211844 | Ain Shams University | Chronyske hepatitis C | 1 oktober 2019 |
|
| NCT00874770 | Bristol-Myers Squibb | Hepatitis C ynfeksje | juny 2009 | Fase 2 |
| NCT03883698 | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Nierfalen, chronike | Hepatitis C | 15 maart 2019 | Fase 3 |
| NCT01448044 | Bristol-Myers Squibb | Hepatitis C | desimber 2011 | Fase 3 |
| NCT01359644 | Bristol-Myers Squibb|Pharmasset | Chronyske hepatitis C | juny 2011 | Fase 2 |
| NCT01842451 | Fertex Pharmaceuticals Incorporated | Chronyske hepatitis C | CHC | HCV | Hepatitis C | juny 2013 | Fase 2 |
| NCT02762448 | Tainan Municipal Sikehûs | Hepatitis c | july 2016 |
|
| NCT02473211 | Humanity and Health Research Centre|Beijing 302 Hospital | Chronyske hepatitis C-ynfeksje | Jannewaris 2015 | Fase 2 | Fase 3 |
| NCT01455090 | Bristol-Myers Squibb | Chronyske hepatitis C | 30 novimber 2011 | Fase 2 |
| NCT03490097 | Ain Shams University | Chronyske hepatitis c | Metabolysk syndroom | 1 desimber 2017 | Fase 2 | Fase 3 |
| NCT01170962 | Bristol-Myers Squibb | Hepatitis C firus | augustus 2010 | Fase 2 |
| NCT02333292 | Valme University Hospital|Sikehûs del SAS de Jerez|Sikehûs Algemiene Universitario Elche|Sikehûs La Línea de la Concepción|Complexo Hospitalario Universitario de A Coruña|Sikehûs de Figueres|Sikehûs Universitario Puerto Real|Sikehûs Universitario Virgen de la Victoria|Sikehûs Universitario de Cannes | Sikehûs Algemiene Universitario de Alicante|Sikehûs Universitario Araba|Sikehûs Royo Vilanova|Sikehûs Universitario de Burgos|Complejo Hospitalario Universitario de Huelva|Sikehûs Universitario Reina Sofia de Cordoba|Sikehûs Universitario Virgen Macarena|Complexo Hospitalario Universitario de Vigo|Clinica de Navversidad Universidad Navarra|Sikehûs Universitario San Cecilio|Sikehûs Universitario La Fe|Sikehûs Algemiene Universitario de Valencia|Sikehûs Universitario Infanta Leonor|Sikehûs Universitario de Gran Canaria|Sikehûs Algemiene Universitario Santa Lucía|Centro Penitenciario Alicante 1|Sikehûs Haya Universitario de Carlario | la Luz|Hospital General Universitario de Castellón|Sikehûs Parc Taulí, Sabadell | Chronyske hepatitis C-ynfeksje | desimber 2014 |
|
| NCT03200184 | Teheran Universiteit fan Medyske Wittenskippen | Hepatitis C | 1 septimber 2016 | Fase 4 |
| NCT03188276 | Tredde oansletten sikehûs, Sun Yat-Sen University | Chronyske hepatitis C | 1 febrewaris 2016 | Iere faze 1 |
| NCT01830205 | Bristol-Myers Squibb | Hepatitis C | septimber 2012 | Fase 1 |
Foarstel18Kwaliteitskonsistinsjeevaluaasjeprojekten dy't goedkard binne4, en6projekten binne ûnder goedkarring.
Avansearre ynternasjonaal kwaliteitsbehearsysteem hat in solide basis lein foar ferkeap.
Kwaliteitsbegelieding rint troch de heule libbenssyklus fan it produkt om de kwaliteit en therapeutyske effekt te garandearjen.
Professional Regulatory Affairs-team stipet de kwaliteitseasken tidens de oanfraach en registraasje.
Korea Countec Bottled Packaging Line
Taiwan CVC Bottled Packaging Line
Italië CAM Board Packaging Line
German Fette Compacting Machine
Japan Viswill Tablet Detector
DCS Control Room
Ynternasjonale gearwurking
Ynlânske gearwurking
Skriuw jo berjocht hjir en stjoer it nei ús
