ADYNOVATE Drug Use-Results Survey
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- 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.
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 Number of Participants Who Discontinued the Use of Study Drug Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Number of previously treated patients (PTPs) and previously untreated patients (PUPs) who discontinued the use of ADYNOVATE were reported.
Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Annual bleed rate (ABR) of spontaneous bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Annual bleed rate (ABR) of breakthrough bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Duration of Treatment of Study Drug on a Prophylaxis Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs. Duration of treatment of study drug on a prophylaxis regimen was reported.
Duration of Treatment of Study Drug an On-Demand Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Duration of treatment of study drug on an on-demand regimen was reported.
Dose Per Administration of Study Drug on a Prophylaxis Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Dose per administration of study drug on a prophylaxis regimen was reported.
Dose Per Administration of Study Drug an On-Demand Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Dose per administration of study drug on an on-demand regimen was reported.
Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Number of doses per a bleeding episode of study drug on an on-demand regimen was reported.
Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Percentage of each category of hemostatic effectiveness for treatment of breakthrough bleeding episodes in a prophylaxis regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.
Hemostatic Effectiveness of Study Drug on an On-Demand Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Percentage of each category of hemostatic effectiveness for an on-demand regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.
- Secondary Outcome Measures
Name Time Method Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Number of doses per a week of study drug on a prophylaxis regimen was reported.
Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE) Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs Number of PTPs and PUPs who experienced factor VIII inhibition, dermatitis atopic or eczema as an AE related to development of inhibitors, shock or anaphylaxis was reported.
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