ADYNOVATE Drug Use-Results Survey

Completed

• Conditions: Hemophilia A
• Interventions: Biological: ADYNOVATE

• Registration Number: NCT03169972
• Lead Sponsor: Takeda

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

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Exclusion Criteria

• Patients not administered ADYNOVATE.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Previously untreated patients (PUPs)	ADYNOVATE	PUPs: patients who had 3 or less previous exposure days to other products
Previously treated patients (PTPs)	ADYNOVATE	PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products

Primary Outcome Measures

Name	Time	Method
Participants who discontinued the use of ADYNOVATE - previously treated patients (PTPs)	Throughout the study participation period: 1 year for previously treated patients (PTPs)	Number of PTPs who discontinued the use of ADYNOVATE
Annual bleed rate (ABR) - previously untreated patients (PUPs)	Throughout the study participation period: 2 years for previously untreated patients (PUPs)	Annual bleed rate (ABR) of PUPs on a prophylaxis regimen
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously treated patients (PTPs)	At bleed resolution throughout the study participation period: 1 year for previously treated patients (PTPs)	Based on a 4-point ordinal scale (poor, fair, good, excellent)
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously untreated patients (PUPs)	At bleed resolution throughout the study participation period: 2 years for previously untreated patients (PUPs).	Based on a 4-point ordinal scale (poor, fair, good, excellent)
Participants who discontinued the use of ADYNOVATE - previously untreated patients (PUPs)	Throughout the study participation period: 2 years for previously untreated patients (PUPs)	Number of PUPs who discontinued the use of ADYNOVATE
Participants who developed a Factor VIII (FVIII) inhibitor - previously treated patients (PTPs)	Throughout the study participation period: 1 year for previously treated patients (PTPs)	Number of PTPs who developed a Factor VIII (FVIII) inhibitor
Doses to treat a bleed of participants on an on-demand regimen - previously treated patients (PTPs)	At bleed resolution throughout the study participation period: 1 year for previously treated patients (PTPs)	Number of doses to treat a bleed of PTPs on an on-demand regimen
Annual bleed rate (ABR) - previously treated patients (PTPs)	Throughout the study participation period: 1 year for previously treated patients (PTPs)	Annual bleed rate (ABR) of PTPs on a prophylaxis regimen
Participants who developed a Factor VIII (FVIII) inhibitor - previously untreated patients (PUPs)	Throughout the study participation period: 2 years for previously untreated patients (PUPs)	Number of PUPs who developed a Factor VIII (FVIII) inhibitor
Doses to treat a bleed of participants on an on-demand regimen - previously untreated patients (PUPs)	At bleed resolution throughout the study participation period: 2 years for previously untreated patients (PUPs).	Number of doses to treat a bleed of PUPs on an on-demand regimen

Secondary Outcome Measures

Name	Time	Method
Participants who experience shock or anaphylaxis - previously treated patients (PTPs)	Throughout the study participation period: 1 year for previously treated patients (PTPs)	Number of PTPs who experience shock or anaphylaxis
Participants who experience shock or anaphylaxis - previously untreated patients (PUPs)	Throughout the study participation period: 2 years for previously untreated patients (PUPs)	Number of PUPs who experience shock or anaphylaxis

Trial Locations

Locations (49)

Matsuyama City, Japan; 🇯🇵 Matsuyama City, Ehime Prefecture, Japan

Sapporo City; 🇯🇵 Sapporo City, Hokkaido, Japan

Kyoto City; 🇯🇵 Kyoto City, Kyoto Prefecture, Japan

Setagaya-ku, Japan; 🇯🇵 Setagaya-ku, Tokyo Metropolitan, Japan

Osaka-City, Japan; 🇯🇵 Osaka-City, Osaka Prefecture, Japan

Morioka City, Japan; 🇯🇵 Morioka City, Iwate Prefecture, Japan

Koti City, Japan; 🇯🇵 Koti City, Koti Prefecture, Japan

Sendai City; 🇯🇵 Sendai City, Miyagi Prefecture, Japan

Hirakata City; 🇯🇵 Hirakata City, Osaka Prefecture, Japan

Nishi-ku; 🇯🇵 Nishi-ku, Osaka Prefecture, Japan

Fukuoka-City, Japan; 🇯🇵 Fukuoka-City, Fukuoka Prefecture, Japan

Ogaki City, Japan; 🇯🇵 Ogaki City, Gifu Prefecture, Japan

Kobe City; 🇯🇵 Kobe City, Hyogo Prefecture, Japan

Higashiosaka City; 🇯🇵 Higashiosaka City, Osaka Prefecture, Japan

Kawasaki City, Japan; 🇯🇵 Kawasaki City, Kanagawa Prefecture, Japan

Shinjuku-Ku, Japan; 🇯🇵 Shinjuku-Ku, Tokyo Metropolis, Japan

Toon City; 🇯🇵 Toon City, Ehime Prefecture, Japan

Nishinomiya City, Japan; 🇯🇵 Nishinomiya City, Hyogo Prefecture, Japan

Kudou-Gun, Japan; 🇯🇵 Kudou-Gun, Hokkaido, Japan

Zentuji City, Japan; 🇯🇵 Zentuji City, Kagawa Prefecture, Japan

Minamata City, Japan; 🇯🇵 Minamata City, Kumamoto Prefecture, Japan

Kashiwazaki City; 🇯🇵 Kashiwazaki City, Niigata Prefecture, Japan

Osaka City, Japan; 🇯🇵 Osaka City, Osaka Prefecture, Japan

Matsudo City, Japan; 🇯🇵 Matsudo City, Chiba Prefecture, Japan

Narita City; 🇯🇵 Narita City, Chiba Prefecture, Japan

Sukagawa City; 🇯🇵 Sukagawa City, Fukushima Prefecture, Japan

Hirosaki City; 🇯🇵 Hirosaki City, Aomori Prefecture, Japan

Koriyama City; 🇯🇵 Koriyama City, Fukushima Prefecture, Japan

Nagoya City, Japan; 🇯🇵 Nagoya City, Aichi Prefecture, Japan

Chiba-City, Japan; 🇯🇵 Chiba-City, Chiba Prefecture, Japan

Tsu City, Japan; 🇯🇵 Tsu City, Mie Prefecture, Japan

Matsumoto City; 🇯🇵 Matsumoto City, Nagano Prefecture, Japan

Kurasiki City, Japan; 🇯🇵 Kurasiki City, Okayama Prefecture, Japan

Hiroshima City, Japan; 🇯🇵 Hiroshima City, Hiroshima Prefecture, Japan

Kagoshima City, Japan; 🇯🇵 Kagoshima City, Kagoshima Prefecture, Japan

Maebashi City; 🇯🇵 Maebashi City, Gunma Prefecture, Japan

Jyoetsu City; 🇯🇵 Jyoetsu City, Niigata Prefecture, Japan

Kitakyusyu City, Japan; 🇯🇵 Kitakyusyu City, Fukuoka Prefecture, Japan

Nagano City, Japan; 🇯🇵 Nagano City, Nagano Prefecture, Japan

Sakata City, Japan; 🇯🇵 Sakata City, Yamagata Prefecture, Japan

Yokohama City, Japan; 🇯🇵 Yokohama City, Kanagawa Prefecture, Japan

Tome City, Japan; 🇯🇵 Tome City, Miyagi Prefecture, Japan

Nichinan City; 🇯🇵 Nichinan City, Miyazaki Prefecture, Japan

Tokushima City, Japan; 🇯🇵 Tokushima City, Tokushima Prefecture, Japan

Suginami-ku, Japan; 🇯🇵 Suginami-ku, Tokyo, Japan

Okayama City, Japan; 🇯🇵 Okayama City, Okayama Prefecture, Japan

Koshigaya City, Japan; 🇯🇵 Koshigaya City, Saitama Prefecture, Japan

Saitama-City, Japan; 🇯🇵 Saitama-City, Saitama Prefecture, Japan

Shunan City, Japan; 🇯🇵 Shunan City, Yamagata Prefecture, Japan