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
6,796 miles (10,937 km)  awayfrom
Boston, Massachusetts
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Hirosaki City

036-8004, Japan

Recruiting
6,375 miles (10,260 km)  awayfrom
Boston, Massachusetts
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Chiba-City, Japan

260-8677, Japan

Recruiting
6,701 miles (10,784 km)  awayfrom
Boston, Massachusetts
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Matsudo City, Japan

271-8511, Japan

Recruiting
6,693 miles (10,772 km)  awayfrom
Boston, Massachusetts
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Narita City

Narita, Chiba, Japan

Recruiting
6,686 miles (10,760 km)  awayfrom
Boston, Massachusetts
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Matsuyama City, Japan

790-8524, Japan

Recruiting
6,959 miles (11,199 km)  awayfrom
Boston, Massachusetts
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Toon City

791-0295, Japan

Recruiting
6,960 miles (11,201 km)  awayfrom
Boston, Massachusetts
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Fukuoka-City, Japan

812-8582, Japan

Recruiting
7,014 miles (11,288 km)  awayfrom
Boston, Massachusetts
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Kitakyusyu City, Japan

807-8556, Japan

Recruiting
6,991 miles (11,252 km)  awayfrom
Boston, Massachusetts
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Kitakyusyu City, Japan

807-8556, Japan

Recruiting
6,991 miles (11,252 km)  awayfrom
Boston, Massachusetts
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Koriyama City

963-8585, Japan

Recruiting
6,581 miles (10,592 km)  awayfrom
Boston, Massachusetts
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Sukagawa City

962-8507, Japan

Recruiting
6,588 miles (10,602 km)  awayfrom
Boston, Massachusetts
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Ogaki City, Japan

503-8502, Japan

Recruiting
6,789 miles (10,926 km)  awayfrom
Boston, Massachusetts
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Maebashi City

371-8511, Japan

Recruiting
6,672 miles (10,738 km)  awayfrom
Boston, Massachusetts
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Hiroshima City, Japan

Hiroshima, Japan

Recruiting
6,929 miles (11,151 km)  awayfrom
Boston, Massachusetts
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Kudou-Gun, Japan

049-4501, Japan

Recruiting
6,272 miles (10,093 km)  awayfrom
Boston, Massachusetts
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Sapporo City

060-8648, Japan

Recruiting
6,200 miles (9,978 km)  awayfrom
Boston, Massachusetts
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Kobe City

651-2273, Japan

Recruiting
6,861 miles (11,042 km)  awayfrom
Boston, Massachusetts
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Kobe City

651-2273, Japan

Recruiting
6,861 miles (11,042 km)  awayfrom
Boston, Massachusetts
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Nishinomiya City, Japan

Nishinomiya, Hyogo, Japan

Recruiting
6,854 miles (11,030 km)  awayfrom
Boston, Massachusetts
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Morioka City, Japan

020-8560, Japan

Recruiting
6,421 miles (10,333 km)  awayfrom
Boston, Massachusetts
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Zentuji City, Japan

765-8501, Japan

Recruiting
6,917 miles (11,132 km)  awayfrom
Boston, Massachusetts
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Kagoshima City, Japan

890-0046, Japan

Recruiting
7,146 miles (11,501 km)  awayfrom
Boston, Massachusetts
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Kawasaki City, Japan

216-8511, Japan

Recruiting
6,714 miles (10,805 km)  awayfrom
Boston, Massachusetts
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Yokohama City, Japan

241-0811, Japan

Recruiting
6,722 miles (10,819 km)  awayfrom
Boston, Massachusetts
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Yokohama City, Japan

241-0811, Japan

Recruiting
6,722 miles (10,819 km)  awayfrom
Boston, Massachusetts
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Koti City, Japan

781-8555, Japan

Recruiting
6,965 miles (11,210 km)  awayfrom
Boston, Massachusetts
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Minamata City, Japan

867-0041, Japan

Recruiting
7,107 miles (11,438 km)  awayfrom
Boston, Massachusetts
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Kyoto City

605-0981, Japan

Recruiting
6,830 miles (10,992 km)  awayfrom
Boston, Massachusetts
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Tsu City, Japan

514-8507, Japan

Recruiting
6,831 miles (10,993 km)  awayfrom
Boston, Massachusetts
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Sendai City

983-8520, Japan

Recruiting
6,515 miles (10,485 km)  awayfrom
Boston, Massachusetts
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Tome City, Japan

987-0511, Japan

Recruiting
6,482 miles (10,432 km)  awayfrom
Boston, Massachusetts
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Nichinan City

887-0013, Japan

Recruiting
7,132 miles (11,477 km)  awayfrom
Boston, Massachusetts
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Matsumoto City

390-8621, Japan

Recruiting
6,704 miles (10,790 km)  awayfrom
Boston, Massachusetts
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Nagano City, Japan

380-0928, Japan

Recruiting
6,676 miles (10,744 km)  awayfrom
Boston, Massachusetts
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Jyoetsu City

943-0147, Japan

Recruiting
6,644 miles (10,692 km)  awayfrom
Boston, Massachusetts
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Kashiwazaki City

945-0035, Japan

Recruiting
6,621 miles (10,655 km)  awayfrom
Boston, Massachusetts
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Kurasiki City, Japan

701-0192, Japan

Recruiting
6,889 miles (11,087 km)  awayfrom
Boston, Massachusetts
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Okayama City, Japan

700-8558, Japan

Recruiting
6,886 miles (11,082 km)  awayfrom
Boston, Massachusetts
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Higashiosaka City

578-8588, Japan

Recruiting
6,854 miles (11,030 km)  awayfrom
Boston, Massachusetts
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Hirakata City

573-1191, Japan

Recruiting
6,843 miles (11,013 km)  awayfrom
Boston, Massachusetts
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Nishi-ku

593-8304, Japan

Recruiting
6,864 miles (11,047 km)  awayfrom
Boston, Massachusetts
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Osaka City, Japan

540-0006, Japan

Recruiting
6,854 miles (11,031 km)  awayfrom
Boston, Massachusetts
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Osaka-City, Japan

554-0012, Japan

Recruiting
6,855 miles (11,033 km)  awayfrom
Boston, Massachusetts
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Koshigaya City, Japan

343-8555, Japan

Recruiting
6,691 miles (10,768 km)  awayfrom
Boston, Massachusetts
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Saitama-City, Japan

330-8777, Japan

Recruiting
6,693 miles (10,772 km)  awayfrom
Boston, Massachusetts
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Tokushima City, Japan

770-8503, Japan

Recruiting
6,913 miles (11,125 km)  awayfrom
Boston, Massachusetts
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Shinjuku-Ku, Japan

160-0023, Japan

Recruiting
6,705 miles (10,790 km)  awayfrom
Boston, Massachusetts
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Setagaya-ku, Japan

157-8535, Japan

Recruiting
6,710 miles (10,799 km)  awayfrom
Boston, Massachusetts
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Suginami-ku, Japan

167-0035, Japan

Recruiting
6,705 miles (10,791 km)  awayfrom
Boston, Massachusetts
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Sakata City, Japan

998-8501, Japan

Recruiting
6,497 miles (10,456 km)  awayfrom
Boston, Massachusetts
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Shunan City, Japan

745-8522, Japan

Recruiting
6,962 miles (11,204 km)  awayfrom
Boston, Massachusetts
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View all (52)
Trial Protocol ID: 261601
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