Daclatasvir dihydrochloride
Katerangan
Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) nyaéta potent sareng aktip sacara lisan.Protéin HCV NS5Ainhibitor kalawanEC50s rentang 9-146 pm pikeunsababaraha genotypes réplika HCV.Daclatasvir dihydrochloride ogé mangrupaanion organik ngangkut polipéptida 1B (OATP1B)jeungOATP1B3inhibitor kalawanIC50s tina 1,5 µM sareng 3,27 µM, masing-masing.
IC50& Sasaran
EC50: 50 pM (HCV replicon genotype 1a), 9 pM (HCV replicon genotype 1b), 71 pM (HCV replicon genotype 2a), 146 pM (HCV replicon genotype 3a), 12 pM (HCV replicon genotype 4a) jeung HCV réplika genotip 5a)[1]
Kd: 8 nM (NS5A33-202) jeung 210 nM (NS5A26-202)[2]
IC50: 1,5 µM (OATP1B) sareng 3,27 µM (OATP1B3)[3]
Dina Vitro
Daclatasvir (BMS-790052) nunjukkeun kagiatan ngahambat anu kuat pikeun sadaya genotip anu diuji, kalayan EC50nilai mimitian ti 9 pm nepi ka 146 pm.Daclatasvir ngahambat genotip réplika HCV 1a, 1b, 2a, 3a, 4a sareng 5a kalayan EC5050 pm, 9 pm, 71 pm, 146 pm, 12 pm jeung 33 pm, masing-masing.Daclatasvir mangrupakeun inhibitor potent tina JFH-1 genotype 2a virus inféksi nu réplikasi dina kultur sél (EC).50= 28 WIB)[1].Daclatasvir (BMS-790052) ngabeungkeut pageuh kana NS5A33-202 sareng NS5A26-202 sareng Kds masing-masing 8 nM sareng 210 nM[2].
Panyimpenan
| Bubuk | -20°C | 3 taun |
| 4°C | 2 taun | |
| Dina pangleyur | -80°C | 6 bulan |
| -20°C | 1 bulan |
Uji klinis
| Nomer NCT | Sponsor | Kaayaan | Tanggal mimiti | Fase |
| NCT03369327 | Tehran Universitas Élmu Médis|RojanPharma Pharmaceutical Company | Inféksi Virus Hépatitis C, Tanggapan kana Terapi|Virus Kakurangan Imun Manusa | 1 Januari 2017 | Fase 3 |
| NCT03485846 | R-Pharm|Almedis | Hépatitis C kronis Genotip 1b | 27 Nopémber 2017 | Fase 2 |
| NCT01016912 | Bristol-Myers Squibb | Inféksi Hépatitis C | Désémber 2009 | Fase 2 |
| NCT01629732 | Bristol-Myers Squibb | Virus Hépatitis C | Maret 2013 | Fase 2 |
| NCT01497834 | Bristol-Myers Squibb | Hépatitis C | Januari 2012 | Fase 3 |
| NCT01973049 | Bristol-Myers Squibb | Hépatitis C | Désémber 2013 | Fase 3 |
| NCT00663208 | Bristol-Myers Squibb | Hépatitis C kronis | Méi 2008 | Fase 2 |
| NCT02576314 | Puseur Panalungtikan Kamanusaan sarta Kaséhatan|Beijing 302 Rumah Sakit | Inféksi Hépatitis C kronis | Méi 2015 | Fase 3 |
| NCT02756936 | Pusat Panalungtikan Asli, Mesir|Zeta Pharma Pharmaceutical Industries | Sehat | Pébruari 2016 | Fase 1 |
| NCT02771405 | Hepatologi Nasional & Institut Panaliti Kedokteran Tropis|Universitas Kairo | Hépatitis C, Kronis|Karsinoma Hépatoseluler | Maret 2016 | Fase 3 |
| NCT03706898 | Viriom | HIV-1-inféksi|Hépatik Impairment | 1 Oktober 2018 | Fase 1 |
| NCT02319031 | Bristol-Myers Squibb | Hépatitis C | Pébruari 2015 | Fase 3 |
| NCT02124044 | National Institutes of Health Clinical Center (CC)|Institut Nasional Alergi sareng Panyakit Inféksi (NIAID)|Bristol-Myers Squibb | HIV-HCV | Pébruari 2014 | Fase 2 |
| NCT02551861 | Bristol-Myers Squibb | Hépatitis C | Désémber 2015 | Fase 2 |
| NCT00859053 | Bristol-Myers Squibb | Insufficiency hépatik | Maret 2009 | Fase 1 |
| NCT01257204 | Bristol-Myers Squibb | Virus Hépatitis C | Désémber 2010 | Fase 2 |
| NCT03063879 | Universitas Élmu Médis Teheran|Universitas Élmu Médis Ahvaz Jundishapur|Universitas Élmu Médis Shiraz|Universitas Élmu Médis Hamadan | Hépatitis C, Kronis|Gagal Ginjal Kronis | 1 April 2017 | Fase 4 |
| NCT01017575 | Bristol-Myers Squibb | Inféksi Hépatitis C | Désémber 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 | Hépatitis C kronis | Séptémber 2016 |
|
| NCT04070235 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Hépatitis C, kronis | 29 Maret 2019 | Fase 2|Fase 3 |
| NCT03487848 | Bristol-Myers Squibb | Hépatitis C|Hépatitis Kronis | 18 Méi 2018 | Fase 2 |
| NCT00904059 | Bristol-Myers Squibb | Hépatitis C | Méi 2009 | Fase 1 |
| NCT02107365 | Institut Nasional Perancis pikeun Panaliti Kaséhatan sareng Médis-Badan Nasional Perancis pikeun Panaliti AIDS sareng Hépatitis Viral (Inserm-ANRS)|Bristol-Myers Squibb | Hépatitis C Virus Genotype 4 Inféksi | Nopémber 2013 | Fase 2 |
| NCT02397395 | Janssen R & D Irlandia | Karusakan Ginjal|Panyakit Ginjal Tahap Ahir | Méi 2015 | Fase 2 |
| NCT03169348 | Universitas Assiut | Hépatitis C | 1 Nopémber 2017 | Henteu tiasa dianggo |
| NCT02323594 | Bristol-Myers Squibb | Inféksi Hépatitis C | Désémber 2014 | Fase 1 |
| NCT03537196 | Institut Nasional Perancis pikeun Panalungtikan Kaséhatan sareng Médis-Badan Nasional Perancis pikeun Panaliti AIDS sareng Hépatitis Viral (Inserm-ANRS) | Hépatitis C|Pamakéan Narkoba|Hépatitis C Viral | 13 Nopémber 2018 | Fase 4 |
| NCT02103569 | Bristol-Myers Squibb | Hépatitis C | April 2014 | Fase 1 |
| NCT02772744 | Universitas Zagazig|Universitas Kairo | Hépatitis C | 1 Nopémber 2017 |
|
| NCT01718158 | Bristol-Myers Squibb | Hépatitis C | Januari 2013 | Fase 3 |
| NCT02496078 | Bristol-Myers Squibb | Hépatitis C | Agustus 2015 | Fase 3 |
| NCT01425970 | Bristol-Myers Squibb | Hépatitis C | Méi 2012 | Fase 2 |
| NCT01471574 | Bristol-Myers Squibb | Hépatitis C, Genotip 1 | Désémber 2011 | Fase 3 |
| NCT01573351 | Bristol-Myers Squibb | Virus Hépatitis C | Méi 2012 | Fase 3 |
| NCT01938625 | Janssen R & D Irlandia | Hépatitis C, kronis | 12 Désémber 2013 | Fase 2 |
| NCT01492426 | Bristol-Myers Squibb | Hépatitis C | Januari 2012 | Fase 3 |
| NCT03480932 | Johns Hopkins Bloomberg Sakola Kaséhatan Umum|Institut Nasional pikeun Nyalahgunakeun Narkoba (NIDA)|Puseur YR Gaitonde pikeun Panaliti sareng Atikan AIDS | Hépatitis C, kronis | 2 Pébruari 2018 | Fase 2|Fase 3 |
| NCT03163849 | Universitas Assiut | Hépatitis kronis c | 1 Séptémber 2019 | Fase 3 |
| NCT01581203 | Bristol-Myers Squibb | Virus Hépatitis C | Méi 2012 | Fase 3 |
| NCT01492504 | Bristol-Myers Squibb | Hépatitis C | 7 Pébruari 2012 |
|
| NCT03686722 | Mohamed Raslan|Universitas Ain Shams|Pusat Panalungtikan Narkoba, Kairo, Mesir | Diabetes Mellitus, Tipe 2|Hépatitis C|Interaksi Narkoba | 9 Séptémber 2017 | Fase 1 |
| NCT02262728 | Janssen Panalungtikan & Pangwangunan, LLC | Hépatitis C, kronis | 30 Séptémber 2014 | Fase 2 |
| NCT02349048 | Janssen Panalungtikan & Pangwangunan, LLC | Virus Hépatitis C | Januari 2015 | Fase 2 |
| NCT03882307 | Universitas Assiut | Hépatitis C, kronis | Méi 2020 | Fase Awal 1 |
| NCT02758509 | Parc de Salut Mar | Hépatitis C | Sirosis kronis | 1 Januari 2010 |
|
| NCT01795911 | Bristol-Myers Squibb | Hépatitis C | Maret 2013 | Fase 2 |
| NCT03549832 | Universitas Assiut|Universitas Sohag|Universitas Lembah Kidul | Koinfeksi HCV | 1 Januari 2018 | Henteu tiasa dianggo |
| NCT02161939 | Bristol-Myers Squibb | Hépatitis C kronis |
| |
| NCT01309932 | Bristol-Myers Squibb | Hépatitis C | Maret 2011 | Fase 2 |
| NCT01995266 | Bristol-Myers Squibb | Hépatitis C | 28 Pébruari 2014 | Fase 3 |
| NCT02640157 | AbbVie | Hépatitis C kronis|Virus Hépatitis C|Virus Hépatitis C Genotip 3 | Désémber 2015 | Fase 3 |
| NCT02032875 | Bristol-Myers Squibb | Hépatitis C | Maret 2014 | Fase 3 |
| NCT02624063 | Universitas Féderal São Paulo | Hépatitis C, kronis | Désémber 2015 | Fase 4 |
| NCT00546715 | Bristol-Myers Squibb | Hépatitis C kronis | Nopémber 2007 | Fase 1|Fase 2 |
| NCT01718145 | Bristol-Myers Squibb | Inféksi Virus Hépatitis C | Nopémber 2012 | Fase 3 |
| NCT01616524 | Bristol-Myers Squibb | Virus Hépatitis C (HCV) | Juli 2012 | Fase 3 |
| NCT02032901 | Bristol-Myers Squibb | Hépatitis C | Januari 2014 | Fase 3 |
| NCT03540212 | Universitas Ain Shams | Inféksi HCV kronis | 10 Désémber 2017 | Fase 2|Fase 3 |
| NCT02097966 | Bristol-Myers Squibb | Hépatitis C kronis |
| |
| NCT02596880 | Universitas Élmu Médis Teheran | Hépatitis C | Sirosis | Séptémber 2015 | Fase 3 |
| NCT04019717 | Atea Pharmaceuticals, Nyarita. | Hépatitis C|Hépatitis C, Kronis|Hépatitis C kronis|Inféksi Virus Hépatitis C|Inféksi HCV | 20 Juni 2019 | Fase 2 |
| NCT02992457 | Universitas Tanta | Hépatitis C | Januari 2015 | Fase 4 |
| NCT03547895 | Universitas Zagazig | Sirosis dekompensasi | 1 Juni 2015 | Henteu tiasa dianggo |
| NCT03004625 | Kaohsiung Medical University Chung-Ho Memorial Hospital|Chang Gung Memorial Hospital|National Taiwan University Hospital|Taipei Veterans General Hospital, Taiwan|China Medical University Hospital|National Cheng-Kung University Hospital | Hépatitis C | Nopémber 2016 | Fase 3 |
| NCT01051414 | Bristol-Myers Squibb | Inféksi Hépatitis C | April 2010 | Fase 2 |
| NCT02309450 | Institut Nasional Perancis pikeun Panaliti Kaséhatan sareng Médis-Badan Nasional Perancis pikeun Panaliti AIDS sareng Hépatitis Viral (Inserm-ANRS)|Bristol-Myers Squibb | Hépatitis C Virus Genotype 4 Inféksi | Désémber 2014 | Fase 2 |
| NCT01628692 | Bristol-Myers Squibb|Janssen Panalungtikan & Pangwangunan, LLC | Virus Hépatitis C | Juli 2012 | Fase 2 |
| NCT03186313 | Rumah Sakit Hati Mesir|Rumah Sakit Wadi El Nil | Hépatitis C | Séptémber 2016 | Fase 3 |
| NCT03063723 | Rumah Sakit Gabungan Katilu, Universitas Sun Yat-Sen | Hépatitis C kronis (Gangguan) | 1 Januari 2016 |
|
| NCT00983957 | Bristol-Myers Squibb | Hépatitis C kronis | Oktober 2009 | Fase 1 |
| NCT01725542 | Institut Nasional Perancis pikeun Panaliti Kaséhatan sareng Médis-Badan Nasional Perancis pikeun Panaliti AIDS sareng Hépatitis Viral (Inserm-ANRS)|Bristol-Myers Squibb | HCV-HIV Co-Inféksi | Désémber 2012 | Fase 2 |
| NCT02282709 | Yayasan pikeun Panalungtikan Ati | Hépatitis C kronis | Pébruari 2014 | Fase 3 |
| NCT02032888 | Bristol-Myers Squibb | Hépatitis C | Pébruari 2014 | Fase 3 |
| NCT03247296 | Universitas MTI | Hépatitis C | Pébruari 28, 2017 |
|
| NCT01389323 | Bristol-Myers Squibb | Hépatitis C | Séptémber 2011 | Fase 3 |
| NCT02556086 | Bristol-Myers Squibb | Hépatitis C | Désémber 2015 | Fase 2 |
| NCT01741545 | Bristol-Myers Squibb | Virus Hépatitis C | 31 Maret 2013 | Fase 3 |
| NCT01866930 | Bristol-Myers Squibb | Inféksi Hépatitis C kronis | 11 Juli 2013 | Fase 3 |
| NCT02268864 | Janssen-Cilag International NV | Hépatitis C, kronis | Januari 2015 | Fase 2 |
| NCT01797848 | Bristol-Myers Squibb | Hépatitis C | Juni 2014 | Fase 3 |
| NCT03166280 | Eman Sayed Hassan Abd Allah|Universitas Assiut | Hépatitis C | Juni 2017 |
|
| NCT02159352 | Bristol-Myers Squibb | Hépatitis C | Juni 2014 | Fase 1 |
| NCT01125189 | Bristol-Myers Squibb | Virus Hépatitis C | Juli 2010 | Fase 2 |
| NCT03748745 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Interaksi Narkoba | 19 Nopémber 2018 | Fase 1 |
| NCT01012895 | Bristol-Myers Squibb | Hépatitis C kronis | Désémber 2009 | Fase 2 |
| NCT02565888 | Universitas Radboud | Hépatitis C|HIV | Nopémber 2015 | Fase 1 |
| NCT02555943 | Puseur Panalungtikan Kamanusaan sarta Kaséhatan|Beijing 302 Rumah Sakit|Rumah Sakit Nanfang Universitas Médis Kidul | Inféksi Hépatitis C kronis|Koinfeksi HBV|Reaktivasi Hépatitis B | Pébruari 2015 | Fase 2|Fase 3 |
| NCT02304159 | Tarek I. Hassanein, MD, FACP, FAG, AGAF|Puseur Panalungtikan California Kidul | Hépatitis C | Sirosis | Januari 2015 | Fase 4 |
| NCT02580474 | Myeong Jun Song|Bristol-Myers Squibb|Rumah Sakit Universitas Soonchunhyang|Universitas Dankook|Rumah Sakit Universitas Nasional Chungnam|Rumah Sakit Universitas Konyang|Rumah Sakit Universitas Eulji|Rumah Sakit Saint Vincent, Koréa|Rumah Sakit Universitas Konkuk|Rumah Sakit Cheongju St. Mary, Cheongju , Korea|Rumah Sakit Pesangon|Rumah Sakit Guro Universitas Korea|Rumah Sakit Umum Eulji|Universitas Katolik Korea | Hépatitis C | Pébruari 2016 | Fase 4 |
| NCT02104843 | Bristol-Myers Squibb | Hépatitis C | April 2014 | Fase 1 |
| NCT01428063 | Bristol-Myers Squibb | Inféksi Virus Hépatitis C | Séptémber 2011 | Fase 2 |
| NCT02123654 | Bristol-Myers Squibb | Inféksi Virus Hépatitis C | April 2014 | Fase 3 |
| NCT02565862 | Universitas Radboud | Hépatitis C | Diabetik Mellitus | Résistansi Insulin | Januari 2016 | Fase 1 |
| NCT04211844 | Universitas Ain Shams | Hépatitis C kronis | 1 Oktober 2019 |
|
| NCT00874770 | Bristol-Myers Squibb | Inféksi Hépatitis C | Juni 2009 | Fase 2 |
| NCT03883698 | Sanjay Gandhi Pascasarjana Institut Élmu Médis | Gagal ginjal, kronis|Hépatitis C | 15 Maret 2019 | Fase 3 |
| NCT01448044 | Bristol-Myers Squibb | Hépatitis C | Désémber 2011 | Fase 3 |
| NCT01359644 | Bristol-Myers Squibb|Pharmasset | Hépatitis C kronis | Juni 2011 | Fase 2 |
| NCT01842451 | Vertex Pharmaceuticals Incorporated | Hépatitis C|CHC|HCV|Hépatitis C | Juni 2013 | Fase 2 |
| NCT02762448 | Rumah Sakit Kota Tainan | Hépatitis c | Juli 2016 |
|
| NCT02473211 | Puseur Panalungtikan Kamanusaan sarta Kaséhatan|Beijing 302 Rumah Sakit | Inféksi Hépatitis C kronis | Januari 2015 | Fase 2|Fase 3 |
| NCT01455090 | Bristol-Myers Squibb | Hépatitis C kronis | 30 Nopémber 2011 | Fase 2 |
| NCT03490097 | Universitas Ain Shams | Hépatitis kronis c|Sindrom métabolik | 1 Désémber 2017 | Fase 2|Fase 3 |
| NCT01170962 | Bristol-Myers Squibb | Virus Hépatitis C | Agustus 2010 | Fase 2 |
| NCT02333292 | Rumah Sakit Universitas Valme|Hospital del SAS de Jerez|Hospital General Universitario Elche|Hospital La Línea de la Concepción|Complexo Hospitalario Universitario de A Coruña|Hospital de Figueres|Hospital Universitario Puerto Real|Hospital Universitario Virgen de la Victoria|Hospital Universitario de Canarias Hospital General Universitario de Alicante|Hospital Universitario Araba|Hospital Royo Vilanova|Hospital Universitario de Burgos|Complejo Hospitalario Universitario de Huelva|Hospital Universitario Reina Sofia de Cordoba|Hospital Universitario Virgen Macarena|Complexo Hospitalario Universitario de Vigo| Navarra|Hospital Clinico Universitario San Cecilio|Hospital Universitario La Fe|Hospital General Universitario de Valencia|Hospital Universitario Infanta Leonor|Hospital Universitario de Gran Canaria|Hospital General Universitario Santa Lucía|Centro Penitenciario Alicante 1|Hospital Virgen Regional Universitario|Hospital la Luz|Rumah Sakit Umum Universitario de Castellón|Rumah Sakit Parc Taulí, Sabadell | Inféksi Hépatitis C kronis | Désémber 2014 |
|
| NCT03200184 | Universitas Élmu Médis Teheran | Hépatitis C | 1 Séptémber 2016 | Fase 4 |
| NCT03188276 | Rumah Sakit Gabungan Katilu, Universitas Sun Yat-Sen | Hépatitis C kronis | 1 Pébruari 2016 | Fase Awal 1 |
| NCT01830205 | Bristol-Myers Squibb | Hépatitis C | Séptémber 2012 | Fase 1 |
Usul18Proyék Evaluasi Konsistensi Kualitas anu parantos disatujuan4, jeung6proyék sahandapeun nyatujuan.
Sistem manajemen kualitas internasional anu canggih parantos netepkeun dasar anu kuat pikeun penjualan.
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Tim Urusan Regulasi Profesional ngadukung tungtutan kualitas salami aplikasi sareng pendaptaran.
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