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ADYNOVATE Drug Use-Results Survey

IDENTIFIERS
Trial Protocol: 261601
Clinicaltrials.gov: NCT03169972
PURPOSE

The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients: 1) Unexpected adverse drug reactions 2) Occurrence of adverse drug reactions in the actual clinical use 3) Factors that may affect safety and efficacy 4) Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A) 5) Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy

Recruiting
JP

Trial at a glance

What medical condition is being studied?   Hemophilia A
What is the trial testing?   ADYNOVATE
How many participants are being enrolled?   130
When is the trial being conducted?    - 
How long is participation in the trial?   Patients with hemophilia A (congenital blood coagulation factor VIII deficiency) who receive ADYNOVATE.

Key requirements

Sex   
All
Age   
From 12 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial phase:   N/A
Trial Type:   Observational
Trial Arms/Groups or Cohorts:   
Previously treated patients (PTPs): PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products
Previously untreated patients (PUPs): PUPs: patients who had 3 or less previous exposure days to other products
Intervention:   ADYNOVATE
Primary Outcome Measure(s):   
Participants who discontinued the use of ADYNOVATE - previously treated patients (PTPs) [Time Frame: Throughout the study participation period: 1 year for previously treated patients (PTPs)]
Participants who discontinued the use of ADYNOVATE - previously untreated patients (PUPs) [Time Frame: Throughout the study participation period: 2 years for previously untreated patients (PUPs)]
Participants who developed a Factor VIII (FVIII) inhibitor - previously treated patients (PTPs) [Time Frame: Throughout the study participation period: 1 year for previously treated patients (PTPs)]
Participants who developed a Factor VIII (FVIII) inhibitor - previously untreated patients (PUPs) [Time Frame: Throughout the study participation period: 2 years for previously untreated patients (PUPs)]
Annual bleed rate (ABR) - previously treated patients (PTPs) [Time Frame: Throughout the study participation period: 1 year for previously treated patients (PTPs)]
Annual bleed rate (ABR) - previously untreated patients (PUPs) [Time Frame: Throughout the study participation period: 2 years for previously untreated patients (PUPs)]
Doses to treat a bleed of participants on an on-demand regimen - previously treated patients (PTPs) [Time Frame: At bleed resolution throughout the study participation period: 1 year for previously treated patients (PTPs)]
Doses to treat a bleed of participants on an on-demand regimen - previously untreated patients (PUPs) [Time Frame: At bleed resolution throughout the study participation period: 2 years for previously untreated patients (PUPs).]
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously treated patients (PTPs) [Time Frame: At bleed resolution throughout the study participation period: 1 year for previously treated patients (PTPs)]
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously untreated patients (PUPs) [Time Frame: At bleed resolution throughout the study participation period: 2 years for previously untreated patients (PUPs).]
Secondary Outcome Measure(s):   
Participants who experience shock or anaphylaxis - previously treated patients (PTPs) [Time Frame: Throughout the study participation period: 1 year for previously treated patients (PTPs)]
Participants who experience shock or anaphylaxis - previously untreated patients (PUPs) [Time Frame: Throughout the study participation period: 2 years for previously untreated patients (PUPs)]
Entry Criteria:
Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE Patients not administered ADYNOVATE

Trial Locations

Any
Recruiting
Any
RESULTS
Nagoya City, Japan

466-8560, Japan

Recruiting
126 miles (203 km)  awayfrom
日本
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Hirosaki City

036-8004, Japan

Recruiting
308 miles (496 km)  awayfrom
日本
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Chiba-City, Japan

260-8677, Japan

Recruiting
102 miles (164 km)  awayfrom
日本
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Matsudo City, Japan

271-8511, Japan

Recruiting
85 miles (136 km)  awayfrom
日本
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Narita City

Narita, Chiba, Japan

Recruiting
105 miles (169 km)  awayfrom
日本
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Matsuyama City, Japan

790-8524, Japan

Recruiting
373 miles (600 km)  awayfrom
日本
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Toon City

791-0295, Japan

Recruiting
369 miles (594 km)  awayfrom
日本
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Fukuoka-City, Japan

812-8582, Japan

Recruiting
501 miles (806 km)  awayfrom
日本
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Kitakyusyu City, Japan

807-8556, Japan

Recruiting
478 miles (768 km)  awayfrom
日本
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Kitakyusyu City, Japan

807-8556, Japan

Recruiting
478 miles (768 km)  awayfrom
日本
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Koriyama City

963-8585, Japan

Recruiting
121 miles (195 km)  awayfrom
日本
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Sukagawa City

962-8507, Japan

Recruiting
117 miles (189 km)  awayfrom
日本
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Ogaki City, Japan

503-8502, Japan

Recruiting
131 miles (211 km)  awayfrom
日本
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Maebashi City

371-8511, Japan

Recruiting
26 miles (42 km)  awayfrom
日本
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Hiroshima City, Japan

Hiroshima, Japan

Recruiting
372 miles (599 km)  awayfrom
日本
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Kudou-Gun, Japan

049-4501, Japan

Recruiting
422 miles (679 km)  awayfrom
日本
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Sapporo City

060-8648, Japan

Recruiting
485 miles (780 km)  awayfrom
日本
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Kobe City

651-2273, Japan

Recruiting
232 miles (373 km)  awayfrom
日本
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Kobe City

651-2273, Japan

Recruiting
232 miles (373 km)  awayfrom
日本
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Nishinomiya City, Japan

Nishinomiya, Hyogo, Japan

Recruiting
215 miles (346 km)  awayfrom
日本
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Morioka City, Japan

020-8560, Japan

Recruiting
266 miles (428 km)  awayfrom
日本
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Zentuji City, Japan

765-8501, Japan

Recruiting
310 miles (499 km)  awayfrom
日本
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Kagoshima City, Japan

890-0046, Japan

Recruiting
568 miles (914 km)  awayfrom
日本
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Kawasaki City, Japan

216-8511, Japan

Recruiting
76 miles (123 km)  awayfrom
日本
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Yokohama City, Japan

241-0811, Japan

Recruiting
81 miles (130 km)  awayfrom
日本
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Yokohama City, Japan

241-0811, Japan

Recruiting
81 miles (130 km)  awayfrom
日本
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Koti City, Japan

781-8555, Japan

Recruiting
345 miles (556 km)  awayfrom
日本
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Minamata City, Japan

867-0041, Japan

Recruiting
549 miles (883 km)  awayfrom
日本
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Kyoto City

605-0981, Japan

Recruiting
186 miles (299 km)  awayfrom
日本
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Tsu City, Japan

514-8507, Japan

Recruiting
162 miles (261 km)  awayfrom
日本
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Sendai City

983-8520, Japan

Recruiting
182 miles (292 km)  awayfrom
日本
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Tome City, Japan

987-0511, Japan

Recruiting
213 miles (344 km)  awayfrom
日本
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Nichinan City

887-0013, Japan

Recruiting
528 miles (851 km)  awayfrom
日本
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Matsumoto City

390-8621, Japan

Recruiting
35 miles (57 km)  awayfrom
日本
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Nagano City, Japan

380-0928, Japan

Recruiting
28 miles (45 km)  awayfrom
日本
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Jyoetsu City

943-0147, Japan

Recruiting
53 miles (85 km)  awayfrom
日本
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Kashiwazaki City

945-0035, Japan

Recruiting
68 miles (109 km)  awayfrom
日本
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Kurasiki City, Japan

701-0192, Japan

Recruiting
295 miles (475 km)  awayfrom
日本
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Okayama City, Japan

700-8558, Japan

Recruiting
289 miles (465 km)  awayfrom
日本
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Higashiosaka City

578-8588, Japan

Recruiting
206 miles (332 km)  awayfrom
日本
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Hirakata City

573-1191, Japan

Recruiting
198 miles (318 km)  awayfrom
日本
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Nishi-ku

593-8304, Japan

Recruiting
217 miles (349 km)  awayfrom
日本
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Osaka City, Japan

540-0006, Japan

Recruiting
209 miles (336 km)  awayfrom
日本
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Osaka-City, Japan

554-0012, Japan

Recruiting
212 miles (341 km)  awayfrom
日本
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Koshigaya City, Japan

343-8555, Japan

Recruiting
76 miles (122 km)  awayfrom
日本
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Saitama-City, Japan

330-8777, Japan

Recruiting
67 miles (108 km)  awayfrom
日本
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Tokushima City, Japan

770-8503, Japan

Recruiting
280 miles (451 km)  awayfrom
日本
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Shinjuku-Ku, Japan

160-0023, Japan

Recruiting
78 miles (126 km)  awayfrom
日本
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Setagaya-ku, Japan

157-8535, Japan

Recruiting
77 miles (124 km)  awayfrom
日本
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Suginami-ku, Japan

167-0035, Japan

Recruiting
73 miles (118 km)  awayfrom
日本
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Sakata City, Japan

998-8501, Japan

Recruiting
186 miles (300 km)  awayfrom
日本
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Shunan City, Japan

745-8522, Japan

Recruiting
414 miles (667 km)  awayfrom
日本
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View all (52)
Trial Protocol ID: 261601
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