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)］	1

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	EUCTR2006-001383-23-IT (EUCTR)	30/06/2006	28/11/2006	Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WILL	Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WILL	patients with severe inherited VWD unresponsive to DDAVP and with frequent bleedings MedDRA version: 8.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease	Trade Name: ALPHANATEINF 1F 1500UI+F 10ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDIINF FL 250UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDIINF FL 500UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATEINF 1F 250UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATEINF 1F 500UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATEINF 1F 1000UI+F 10ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDIINF FL1000UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATEINF 1F 250UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI 250UI*1F 250UI+F 10ML INN or Proposed INN: Coagulation factor VIII	FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 3	Spain;Germany;United Kingdom;Italy

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

EUCTR2006-001383-23-IT
(EUCTR)

30/06/2006

28/11/2006

Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WILL

patients with severe inherited VWD unresponsive to DDAVP and with frequent bleedings
MedDRA version: 8.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease

Trade Name: ALPHANATE*INF 1F 1500UI+F 10ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI*INF FL 250UI+SIR SOLV+S
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 250UI+F 5ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 500UI+F 5ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 1000UI+F 10ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 250UI+F 5ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI 250UI*1F 250UI+F 10ML
INN or Proposed INN: Coagulation factor VIII

FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain;Germany;United Kingdom;Italy