SYNT001 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
61自己免疫性溶血性貧血3

61. 自己免疫性溶血性貧血


臨床試験数 : 137 薬物数 : 127 - (DrugBank : 55) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 153
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2021-001211-90-ES
(EUCTR)
11/08/202102/07/2021ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA) Warm Autoimmune Hemolytic Anemia (WAIHA)
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN1830
INN or Proposed INN: ORILANOLIMAB
Other descriptive name: SYNT001
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2France;United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
2EUCTR2019-004055-37-ES
(EUCTR)
06/05/202010/05/2020ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia WAIHA
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ALXN1830
INN or Proposed INN: ORILANOLIMAB
Other descriptive name: SYNT001
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2Korea, Republic of;Netherlands;Germany;Australia;Belgium;Canada;France;United Kingdom;Italy;Russian Federation;Spain;Taiwan;United States
3NCT03075878
(ClinicalTrials.gov)
January 10, 20183/3/2017A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)A Phase 1B/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)Warm Autoimmune Hemolytic AnemiaDrug: ALXN1830Alexion PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 1/Phase 2United States;Jordan