Clinical trial NCT03169972: ADYNOVATE Drug Use-Results Survey
Official title: ADYNOVATE Drug Use-Results Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia A (congenital blood coagulation factor VIII deficiency) who receive ADYNOVATE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Discontinued the Use of Study Drug
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Duration of Treatment of Study Drug on a Prophylaxis Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs.
measure: Duration of Treatment of Study Drug an On-Demand Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Dose Per Administration of Study Drug on a Prophylaxis Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Dose Per Administration of Study Drug an On-Demand Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Hemostatic Effectiveness of Study Drug on an On-Demand Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Secondary outcomes:
measure: Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
measure: Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE)
timeFrame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Other outcomes:
Locations:
city: Nagoya City
country: Japan
facility: Nagoya City, Japan
state: Aichi Prefecture
city: Hirosaki City
country: Japan
facility: Hirosaki City
state: Aomori Prefecture
city: Chiba-City
country: Japan
facility: Chiba-City, Japan
state: Chiba Prefecture
city: Matsudo City
country: Japan
facility: Matsudo City, Japan
state: Chiba Prefecture
city: Narita City
country: Japan
facility: Narita City
state: Chiba Prefecture
city: Matsuyama City
country: Japan
facility: Matsuyama City, Japan
state: Ehime Prefecture
city: Toon City
country: Japan
facility: Toon City
state: Ehime Prefecture
city: Fukuoka-City
country: Japan
facility: Fukuoka-City, Japan
state: Fukuoka Prefecture
city: Kitakyusyu City
country: Japan
facility: Kitakyusyu City, Japan
state: Fukuoka Prefecture
city: Kitakyusyu City
country: Japan
facility: Kitakyusyu City, Japan
state: Fukuoka Prefecture
city: Koriyama City
country: Japan
facility: Koriyama City
state: Fukushima Prefecture
city: Sukagawa City
country: Japan
facility: Sukagawa City
state: Fukushima Prefecture
city: Ogaki City
country: Japan
facility: Ogaki City, Japan
state: Gifu Prefecture
city: Maebashi City
country: Japan
facility: Maebashi City
state: Gunma Prefecture
city: Hiroshima City
country: Japan
facility: Hiroshima City, Japan
state: Hiroshima Prefecture
city: Kudou-Gun
country: Japan
facility: Kudou-Gun, Japan
state: Hokkaido
city: Sapporo City
country: Japan
facility: Sapporo City
state: Hokkaido
city: Kobe City
country: Japan
facility: Kobe City
state: Hyogo Prefecture
city: Kobe City
country: Japan
facility: Kobe City
state: Hyogo Prefecture
city: Nishinomiya City
country: Japan
facility: Nishinomiya City, Japan
state: Hyogo Prefecture
city: Morioka City
country: Japan
facility: Morioka City, Japan
state: Iwate Prefecture
city: Zentuji City
country: Japan
facility: Zentuji City, Japan
state: Kagawa Prefecture
city: Kagoshima City
country: Japan
facility: Kagoshima City, Japan
state: Kagoshima Prefecture
city: Kawasaki City
country: Japan
facility: Kawasaki City, Japan
state: Kanagawa Prefecture
city: Yokohama City
country: Japan
facility: Yokohama City, Japan
state: Kanagawa Prefecture
city: Yokohama City
country: Japan
facility: Yokohama City, Japan
state: Kanagawa Prefecture
city: Koti City
country: Japan
facility: Koti City, Japan
state: Koti Prefecture
city: Minamata City
country: Japan
facility: Minamata City, Japan
state: Kumamoto Prefecture
city: Kyoto City
country: Japan
facility: Kyoto City
state: Kyoto Prefecture
city: Tsu City
country: Japan
facility: Tsu City, Japan
state: Mie Prefecture
city: Sendai City
country: Japan
facility: Sendai City
state: Miyagi Prefecture
city: Tome City
country: Japan
facility: Tome City, Japan
state: Miyagi Prefecture
city: Nichinan City
country: Japan
facility: Nichinan City
state: Miyazaki Prefecture
city: Matsumoto City
country: Japan
facility: Matsumoto City
state: Nagano Prefecture
city: Nagano City
country: Japan
facility: Nagano City, Japan
state: Nagano Prefecture
city: Jyoetsu City
country: Japan
facility: Jyoetsu City
state: Niigata Prefecture
city: Kashiwazaki City
country: Japan
facility: Kashiwazaki City
state: Niigata Prefecture
city: Kurasiki City
country: Japan
facility: Kurasiki City, Japan
state: Okayama Prefecture
city: Okayama City
country: Japan
facility: Okayama City, Japan
state: Okayama Prefecture
city: Higashiosaka City
country: Japan
facility: Higashiosaka City
state: Osaka Prefecture
city: Hirakata City
country: Japan
facility: Hirakata City
state: Osaka Prefecture
city: Nishi-ku
country: Japan
facility: Nishi-ku
state: Osaka Prefecture
city: Osaka City
country: Japan
facility: Osaka City, Japan
state: Osaka Prefecture
city: Osaka-City
country: Japan
facility: Osaka-City, Japan
state: Osaka Prefecture
city: Koshigaya City
country: Japan
facility: Koshigaya City, Japan
state: Saitama Prefecture
city: Saitama-City
country: Japan
facility: Saitama-City, Japan
state: Saitama Prefecture
city: Tokushima City
country: Japan
facility: Tokushima City, Japan
state: Tokushima Prefecture
city: Shinjuku-Ku
country: Japan
facility: Shinjuku-Ku, Japan
state: Tokyo Metropolis
city: Setagaya-ku
country: Japan
facility: Setagaya-ku, Japan
state: Tokyo Metropolitan
city: Suginami-ku
country: Japan
facility: Suginami-ku, Japan
state: Tokyo
city: Sakata City
country: Japan
facility: Sakata City, Japan
state: Yamagata Prefecture
city: Shunan City
country: Japan
facility: Shunan City, Japan
state: Yamagata Prefecture
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: