62. 発作性夜間ヘモグロビン尿症 Paroxysmal nocturnal hemoglobinuria Clinical trials / Disease details


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108

  
1 trial found
No.TrialIDDate_
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agemin
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agemax
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1EUCTR2017-001418-27-SE
(EUCTR)
20/02/202008/11/2019This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - proposed biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Portugal;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden