DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
288	自己免疫性後天性凝固因子欠乏症［自己免疫性出血病XIII (~2017.3)］	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02973087 (ClinicalTrials.gov)	December 22, 2017	22/11/2016	rVWF IN PROPHYLAXIS	A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE	Von Willebrand Disease	Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)	Baxalta now part of Shire	Baxalta Innovations GmbH, now part of Shire	Completed	18 Years	N/A	All	23	Phase 3	United States;Canada;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey
2	NCT02932618 (ClinicalTrials.gov)	December 18, 2017	12/10/2016	BAX 111 rVWF in Pediatrics	A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF With or Without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed With Severe Von Willebrand Disease	Von Willebrand Disease	Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)	Baxalta now part of Shire	Baxalta Innovations GmbH, now part of Shire	Recruiting	N/A	17 Years	All	34	Phase 3	United States;Austria;Belgium;Czechia;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02973087
(ClinicalTrials.gov)

December 22, 2017

22/11/2016

rVWF IN PROPHYLAXIS

A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE

Von Willebrand Disease

Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)

Baxalta now part of Shire

Baxalta Innovations GmbH, now part of Shire

Completed

18 Years

N/A

All

Phase 3

United States;Canada;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey

NCT02932618
(ClinicalTrials.gov)

December 18, 2017

12/10/2016

BAX 111 rVWF in Pediatrics

A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF With or Without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed With Severe Von Willebrand Disease

Von Willebrand Disease

Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)

Baxalta now part of Shire

Baxalta Innovations GmbH, now part of Shire

Recruiting

N/A

17 Years

All

Phase 3

United States;Austria;Belgium;Czechia;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey;Ukraine;United Kingdom