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)
Nagoya City, Japan
🇯🇵Nagoya City, Aichi Prefecture, Japan
Hirosaki City
🇯🇵Hirosaki City, Aomori Prefecture, Japan
Chiba-City, Japan
🇯🇵Chiba-City, Chiba Prefecture, Japan
Matsudo City, Japan
🇯🇵Matsudo City, Chiba Prefecture, Japan
Narita City
🇯🇵Narita City, Chiba Prefecture, Japan
Matsuyama City, Japan
🇯🇵Matsuyama City, Ehime Prefecture, Japan
Toon City
🇯🇵Toon City, Ehime Prefecture, Japan
Fukuoka-City, Japan
🇯🇵Fukuoka-City, Fukuoka Prefecture, Japan
Kitakyusyu City, Japan
🇯🇵Kitakyusyu City, Fukuoka Prefecture, Japan
Koriyama City
🇯🇵Koriyama City, Fukushima Prefecture, Japan
Scroll for more (39 remaining)Nagoya City, Japan🇯🇵Nagoya City, Aichi Prefecture, Japan