ADYNOVATE Drug Use-Results Survey

Hemophilia A Clinical Trial

Official title:

ADYNOVATE Drug Use-Results Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169972
• Other study ID #: 261601
• Status: Completed
• Start date: April 12, 2017
• Est. completion date: September 15, 2023

Study information

• Verified date: December 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated

Locations

Country	Name	City	State
Japan	Chiba-City, Japan	Chiba-City	Chiba Prefecture
Japan	Fukuoka-City, Japan	Fukuoka-City	Fukuoka Prefecture
Japan	Higashiosaka City	Higashiosaka City	Osaka Prefecture
Japan	Hirakata City	Hirakata City	Osaka Prefecture
Japan	Hirosaki City	Hirosaki City	Aomori Prefecture
Japan	Hiroshima City, Japan	Hiroshima City	Hiroshima Prefecture
Japan	Jyoetsu City	Jyoetsu City	Niigata Prefecture
Japan	Kagoshima City, Japan	Kagoshima City	Kagoshima Prefecture
Japan	Kashiwazaki City	Kashiwazaki City	Niigata Prefecture
Japan	Kawasaki City, Japan	Kawasaki City	Kanagawa Prefecture
Japan	Kitakyusyu City, Japan	Kitakyusyu City	Fukuoka Prefecture
Japan	Kitakyusyu City, Japan	Kitakyusyu City	Fukuoka Prefecture
Japan	Kobe City	Kobe City	Hyogo Prefecture
Japan	Kobe City	Kobe City	Hyogo Prefecture
Japan	Koriyama City	Koriyama City	Fukushima Prefecture
Japan	Koshigaya City, Japan	Koshigaya City	Saitama Prefecture
Japan	Koti City, Japan	Koti City	Koti Prefecture
Japan	Kudou-Gun, Japan	Kudou-Gun	Hokkaido
Japan	Kurasiki City, Japan	Kurasiki City	Okayama Prefecture
Japan	Kyoto City	Kyoto City	Kyoto Prefecture
Japan	Maebashi City	Maebashi City	Gunma Prefecture
Japan	Matsudo City, Japan	Matsudo City	Chiba Prefecture
Japan	Matsumoto City	Matsumoto City	Nagano Prefecture
Japan	Matsuyama City, Japan	Matsuyama City	Ehime Prefecture
Japan	Minamata City, Japan	Minamata City	Kumamoto Prefecture
Japan	Morioka City, Japan	Morioka City	Iwate Prefecture
Japan	Nagano City, Japan	Nagano City	Nagano Prefecture
Japan	Nagoya City, Japan	Nagoya City	Aichi Prefecture
Japan	Narita City	Narita City	Chiba Prefecture
Japan	Nichinan City	Nichinan City	Miyazaki Prefecture
Japan	Nishi-ku	Nishi-ku	Osaka Prefecture
Japan	Nishinomiya City, Japan	Nishinomiya City	Hyogo Prefecture
Japan	Ogaki City, Japan	Ogaki City	Gifu Prefecture
Japan	Okayama City, Japan	Okayama City	Okayama Prefecture
Japan	Osaka City, Japan	Osaka City	Osaka Prefecture
Japan	Osaka-City, Japan	Osaka-City	Osaka Prefecture
Japan	Saitama-City, Japan	Saitama-City	Saitama Prefecture
Japan	Sakata City, Japan	Sakata City	Yamagata Prefecture
Japan	Sapporo City	Sapporo City	Hokkaido
Japan	Sendai City	Sendai City	Miyagi Prefecture
Japan	Setagaya-ku, Japan	Setagaya-ku	Tokyo Metropolitan
Japan	Shinjuku-Ku, Japan	Shinjuku-Ku	Tokyo Metropolis
Japan	Shunan City, Japan	Shunan City	Yamagata Prefecture
Japan	Suginami-ku, Japan	Suginami-ku	Tokyo
Japan	Sukagawa City	Sukagawa City	Fukushima Prefecture
Japan	Tokushima City, Japan	Tokushima City	Tokushima Prefecture
Japan	Tome City, Japan	Tome City	Miyagi Prefecture
Japan	Toon City	Toon City	Ehime Prefecture
Japan	Tsu City, Japan	Tsu City	Mie Prefecture
Japan	Yokohama City, Japan	Yokohama City	Kanagawa Prefecture
Japan	Yokohama City, Japan	Yokohama City	Kanagawa Prefecture
Japan	Zentuji City, Japan	Zentuji City	Kagawa Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

•   To obtain more information on the study, click here/on this link