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:
Inclusion 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. Exclusion Criteria: - Patients not administered ADYNOVATE.

Trial Locations

Any
Recruiting
Any
RESULTS
Nagoya City, Japan

466-8560, Japan

Recruiting
5,571 miles (8,966 km)  awayfrom
Czech Republic
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Hirosaki City

036-8004, Japan

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5,364 miles (8,632 km)  awayfrom
Czech Republic
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Chiba-City, Japan

260-8677, Japan

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5,644 miles (9,083 km)  awayfrom
Czech Republic
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Matsudo City, Japan

271-8511, Japan

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5,627 miles (9,055 km)  awayfrom
Czech Republic
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Narita City

Narita, Chiba, Japan

Recruiting
5,640 miles (9,076 km)  awayfrom
Czech Republic
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Matsuyama City, Japan

790-8524, Japan

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5,511 miles (8,868 km)  awayfrom
Czech Republic
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Toon City

791-0295, Japan

Recruiting
5,517 miles (8,878 km)  awayfrom
Czech Republic
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Fukuoka-City, Japan

812-8582, Japan

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5,444 miles (8,761 km)  awayfrom
Czech Republic
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Kitakyusyu City, Japan

807-8556, Japan

Recruiting
5,439 miles (8,754 km)  awayfrom
Czech Republic
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Kitakyusyu City, Japan

807-8556, Japan

Recruiting
5,439 miles (8,754 km)  awayfrom
Czech Republic
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Koriyama City

963-8585, Japan

Recruiting
5,547 miles (8,927 km)  awayfrom
Czech Republic
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Sukagawa City

962-8507, Japan

Recruiting
5,553 miles (8,937 km)  awayfrom
Czech Republic
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Ogaki City, Japan

503-8502, Japan

Recruiting
5,550 miles (8,932 km)  awayfrom
Czech Republic
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Maebashi City

371-8511, Japan

Recruiting
5,565 miles (8,956 km)  awayfrom
Czech Republic
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Hiroshima City, Japan

Hiroshima, Japan

Recruiting
5,470 miles (8,803 km)  awayfrom
Czech Republic
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Kudou-Gun, Japan

049-4501, Japan

Recruiting
5,242 miles (8,435 km)  awayfrom
Czech Republic
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Sapporo City

060-8648, Japan

Recruiting
5,243 miles (8,439 km)  awayfrom
Czech Republic
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Kobe City

651-2273, Japan

Recruiting
5,535 miles (8,908 km)  awayfrom
Czech Republic
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Kobe City

651-2273, Japan

Recruiting
5,535 miles (8,908 km)  awayfrom
Czech Republic
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Nishinomiya City, Japan

Nishinomiya, Hyogo, Japan

Recruiting
5,545 miles (8,923 km)  awayfrom
Czech Republic
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Morioka City, Japan

020-8560, Japan

Recruiting
5,438 miles (8,751 km)  awayfrom
Czech Republic
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Zentuji City, Japan

765-8501, Japan

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5,523 miles (8,889 km)  awayfrom
Czech Republic
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Kagoshima City, Japan

890-0046, Japan

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5,561 miles (8,949 km)  awayfrom
Czech Republic
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Kawasaki City, Japan

216-8511, Japan

Recruiting
5,627 miles (9,055 km)  awayfrom
Czech Republic
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Yokohama City, Japan

241-0811, Japan

Recruiting
5,632 miles (9,065 km)  awayfrom
Czech Republic
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Yokohama City, Japan

241-0811, Japan

Recruiting
5,632 miles (9,065 km)  awayfrom
Czech Republic
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Koti City, Japan

781-8555, Japan

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5,555 miles (8,941 km)  awayfrom
Czech Republic
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Minamata City, Japan

867-0041, Japan

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5,521 miles (8,886 km)  awayfrom
Czech Republic
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Kyoto City

605-0981, Japan

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5,545 miles (8,923 km)  awayfrom
Czech Republic
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Tsu City, Japan

514-8507, Japan

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5,582 miles (8,984 km)  awayfrom
Czech Republic
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Sendai City

983-8520, Japan

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5,512 miles (8,871 km)  awayfrom
Czech Republic
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Tome City, Japan

987-0511, Japan

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5,496 miles (8,844 km)  awayfrom
Czech Republic
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Nichinan City

887-0013, Japan

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5,590 miles (8,996 km)  awayfrom
Czech Republic
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Matsumoto City

390-8621, Japan

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5,541 miles (8,917 km)  awayfrom
Czech Republic
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Nagano City, Japan

380-0928, Japan

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5,526 miles (8,893 km)  awayfrom
Czech Republic
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Jyoetsu City

943-0147, Japan

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5,501 miles (8,853 km)  awayfrom
Czech Republic
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Kashiwazaki City

945-0035, Japan

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5,495 miles (8,844 km)  awayfrom
Czech Republic
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Kurasiki City, Japan

701-0192, Japan

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5,501 miles (8,853 km)  awayfrom
Czech Republic
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Okayama City, Japan

700-8558, Japan

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5,503 miles (8,857 km)  awayfrom
Czech Republic
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Higashiosaka City

578-8588, Japan

Recruiting
5,557 miles (8,943 km)  awayfrom
Czech Republic
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Hirakata City

573-1191, Japan

Recruiting
5,550 miles (8,932 km)  awayfrom
Czech Republic
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Nishi-ku

593-8304, Japan

Recruiting
5,560 miles (8,949 km)  awayfrom
Czech Republic
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Osaka City, Japan

540-0006, Japan

Recruiting
5,554 miles (8,938 km)  awayfrom
Czech Republic
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Osaka-City, Japan

554-0012, Japan

Recruiting
5,552 miles (8,935 km)  awayfrom
Czech Republic
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Koshigaya City, Japan

343-8555, Japan

Recruiting
5,618 miles (9,041 km)  awayfrom
Czech Republic
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Saitama-City, Japan

330-8777, Japan

Recruiting
5,612 miles (9,032 km)  awayfrom
Czech Republic
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Tokushima City, Japan

770-8503, Japan

Recruiting
5,555 miles (8,941 km)  awayfrom
Czech Republic
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Shinjuku-Ku, Japan

160-0023, Japan

Recruiting
5,626 miles (9,054 km)  awayfrom
Czech Republic
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Setagaya-ku, Japan

157-8535, Japan

Recruiting
5,627 miles (9,055 km)  awayfrom
Czech Republic
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Suginami-ku, Japan

167-0035, Japan

Recruiting
5,622 miles (9,047 km)  awayfrom
Czech Republic
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Sakata City, Japan

998-8501, Japan

Recruiting
5,445 miles (8,762 km)  awayfrom
Czech Republic
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Shunan City, Japan

745-8522, Japan

Recruiting
5,468 miles (8,800 km)  awayfrom
Czech Republic
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View all (52)
Trial Protocol ID: 261601
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