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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

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RESULTS
Nagoya City, Japan

466-8560, Japan

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Hirosaki City

036-8004, Japan

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Chiba-City, Japan

260-8677, Japan

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Matsudo City, Japan

271-8511, Japan

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Narita City

Narita, Chiba, Japan

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Matsuyama City, Japan

790-8524, Japan

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Toon City

791-0295, Japan

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Fukuoka-City, Japan

812-8582, Japan

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Kitakyusyu City, Japan

807-8556, Japan

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Kitakyusyu City, Japan

807-8556, Japan

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Koriyama City

963-8585, Japan

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Sukagawa City

962-8507, Japan

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Ogaki City, Japan

503-8502, Japan

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Maebashi City

371-8511, Japan

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Hiroshima City, Japan

Hiroshima, Japan

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Kudou-Gun, Japan

049-4501, Japan

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Sapporo City

060-8648, Japan

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Kobe City

651-2273, Japan

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Kobe City

651-2273, Japan

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Nishinomiya City, Japan

Nishinomiya, Hyogo, Japan

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Morioka City, Japan

020-8560, Japan

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Zentuji City, Japan

765-8501, Japan

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Kagoshima City, Japan

890-0046, Japan

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Kawasaki City, Japan

216-8511, Japan

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Yokohama City, Japan

241-0811, Japan

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Yokohama City, Japan

241-0811, Japan

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Koti City, Japan

781-8555, Japan

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Minamata City, Japan

867-0041, Japan

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Kyoto City

605-0981, Japan

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Tsu City, Japan

514-8507, Japan

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Sendai City

983-8520, Japan

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Tome City, Japan

987-0511, Japan

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Nichinan City

887-0013, Japan

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Matsumoto City

390-8621, Japan

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Nagano City, Japan

380-0928, Japan

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Jyoetsu City

943-0147, Japan

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Kashiwazaki City

945-0035, Japan

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Kurasiki City, Japan

701-0192, Japan

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Okayama City, Japan

700-8558, Japan

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Higashiosaka City

578-8588, Japan

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Hirakata City

573-1191, Japan

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Nishi-ku

593-8304, Japan

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Osaka City, Japan

540-0006, Japan

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Osaka-City, Japan

554-0012, Japan

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Koshigaya City, Japan

343-8555, Japan

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Saitama-City, Japan

330-8777, Japan

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Tokushima City, Japan

770-8503, Japan

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Shinjuku-Ku, Japan

160-0023, Japan

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Setagaya-ku, Japan

157-8535, Japan

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Suginami-ku, Japan

167-0035, Japan

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Sakata City, Japan

998-8501, Japan

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Shunan City, Japan

745-8522, Japan

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View all (52)
Trial Protocol ID: 261601
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