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

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? Apr 2017 - Dec 2021

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?

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

RESULTS

Nagoya City, Japan

466-8560, Japan

Recruiting

6,835 miles (11,001 km) awayfrom
New York City, New York

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Hirosaki City

036-8004, Japan

Recruiting

6,413 miles (10,321 km) awayfrom
New York City, New York

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Chiba-City, Japan

260-8677, Japan

Recruiting

6,733 miles (10,836 km) awayfrom
New York City, New York

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Matsudo City, Japan

271-8511, Japan

Recruiting

6,726 miles (10,825 km) awayfrom
New York City, New York

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Narita City

Narita, Chiba, Japan

Recruiting

6,718 miles (10,811 km) awayfrom
New York City, New York

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Matsuyama City, Japan

790-8524, Japan

Recruiting

7,007 miles (11,277 km) awayfrom
New York City, New York

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Toon City

791-0295, Japan

Recruiting

7,008 miles (11,278 km) awayfrom
New York City, New York

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Fukuoka-City, Japan

812-8582, Japan

Recruiting

7,068 miles (11,375 km) awayfrom
New York City, New York

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Kitakyusyu City, Japan

807-8556, Japan

Recruiting

7,045 miles (11,338 km) awayfrom
New York City, New York

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Kitakyusyu City, Japan

807-8556, Japan

Recruiting

7,045 miles (11,338 km) awayfrom
New York City, New York

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Koriyama City

963-8585, Japan

Recruiting

6,615 miles (10,646 km) awayfrom
New York City, New York

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Sukagawa City

962-8507, Japan

Recruiting

6,622 miles (10,656 km) awayfrom
New York City, New York

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Ogaki City, Japan

503-8502, Japan

Recruiting

6,830 miles (10,991 km) awayfrom
New York City, New York

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Maebashi City

371-8511, Japan

Recruiting

6,708 miles (10,795 km) awayfrom
New York City, New York

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Hiroshima City, Japan

Hiroshima, Japan

Recruiting

6,979 miles (11,231 km) awayfrom
New York City, New York

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Kudou-Gun, Japan

049-4501, Japan

Recruiting

6,313 miles (10,160 km) awayfrom
New York City, New York

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Sapporo City

060-8648, Japan

Recruiting

6,240 miles (10,042 km) awayfrom
New York City, New York

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Kobe City

651-2273, Japan

Recruiting

6,905 miles (11,112 km) awayfrom
New York City, New York

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Kobe City

651-2273, Japan

Recruiting

6,905 miles (11,112 km) awayfrom
New York City, New York

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Nishinomiya City, Japan

Nishinomiya, Hyogo, Japan

Recruiting

6,897 miles (11,099 km) awayfrom
New York City, New York

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Morioka City, Japan

020-8560, Japan

Recruiting

6,456 miles (10,390 km) awayfrom
New York City, New York

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Zentuji City, Japan

765-8501, Japan

Recruiting

6,963 miles (11,206 km) awayfrom
New York City, New York

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Kagoshima City, Japan

890-0046, Japan

Recruiting

7,198 miles (11,584 km) awayfrom
New York City, New York

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Kawasaki City, Japan

216-8511, Japan

Recruiting

6,747 miles (10,859 km) awayfrom
New York City, New York

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Yokohama City, Japan

241-0811, Japan

Recruiting

6,756 miles (10,872 km) awayfrom
New York City, New York

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Yokohama City, Japan

241-0811, Japan

Recruiting

6,756 miles (10,872 km) awayfrom
New York City, New York

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Koti City, Japan

781-8555, Japan

Recruiting

7,011 miles (11,283 km) awayfrom
New York City, New York

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Minamata City, Japan

867-0041, Japan

Recruiting

7,160 miles (11,522 km) awayfrom
New York City, New York

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Kyoto City

605-0981, Japan

Recruiting

6,872 miles (11,060 km) awayfrom
New York City, New York

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Tsu City, Japan

514-8507, Japan

Recruiting

6,871 miles (11,057 km) awayfrom
New York City, New York

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Sendai City

983-8520, Japan

Recruiting

6,549 miles (10,539 km) awayfrom
New York City, New York

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Tome City, Japan

987-0511, Japan

Recruiting

6,516 miles (10,486 km) awayfrom
New York City, New York

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Nichinan City

887-0013, Japan

Recruiting

7,181 miles (11,557 km) awayfrom
New York City, New York

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Matsumoto City

390-8621, Japan

Recruiting

6,742 miles (10,851 km) awayfrom
New York City, New York

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Nagano City, Japan

380-0928, Japan

Recruiting

6,714 miles (10,805 km) awayfrom
New York City, New York

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Jyoetsu City

943-0147, Japan

Recruiting

6,682 miles (10,754 km) awayfrom
New York City, New York

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Kashiwazaki City

945-0035, Japan

Recruiting

6,659 miles (10,716 km) awayfrom
New York City, New York

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Kurasiki City, Japan

701-0192, Japan

Recruiting

6,936 miles (11,162 km) awayfrom
New York City, New York

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Okayama City, Japan

700-8558, Japan

Recruiting

6,932 miles (11,156 km) awayfrom
New York City, New York

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Higashiosaka City

578-8588, Japan

Recruiting

6,896 miles (11,098 km) awayfrom
New York City, New York

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Hirakata City

573-1191, Japan

Recruiting

6,885 miles (11,080 km) awayfrom
New York City, New York

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Nishi-ku

593-8304, Japan

Recruiting

6,907 miles (11,115 km) awayfrom
New York City, New York

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Osaka City, Japan

540-0006, Japan

Recruiting

6,897 miles (11,099 km) awayfrom
New York City, New York

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Osaka-City, Japan

554-0012, Japan

Recruiting

6,898 miles (11,101 km) awayfrom
New York City, New York

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Koshigaya City, Japan

343-8555, Japan

Recruiting

6,724 miles (10,821 km) awayfrom
New York City, New York

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Saitama-City, Japan

330-8777, Japan

Recruiting

6,727 miles (10,826 km) awayfrom
New York City, New York

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Tokushima City, Japan

770-8503, Japan

Recruiting

6,957 miles (11,196 km) awayfrom
New York City, New York

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Shinjuku-Ku, Japan

160-0023, Japan

Recruiting

6,738 miles (10,844 km) awayfrom
New York City, New York

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Setagaya-ku, Japan

157-8535, Japan

Recruiting

6,744 miles (10,853 km) awayfrom
New York City, New York

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Suginami-ku, Japan

167-0035, Japan

Recruiting

6,739 miles (10,845 km) awayfrom
New York City, New York

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Sakata City, Japan

998-8501, Japan

Recruiting

6,534 miles (10,516 km) awayfrom
New York City, New York

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Shunan City, Japan

745-8522, Japan

Recruiting

7,013 miles (11,286 km) awayfrom
New York City, New York

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View all (52)

Trial Protocol ID: 261601

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