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Completed

NCT Number: NCT03169972

ADYNOVATE Drug Use-Results Survey

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

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya City, Japan, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ADYNOVATE

Biological

Antihemophilic Factor (Recombinant), PEGylated

Other names: BAX 855, BAX855, Recombinant Factor VIII (FVIII) PEGylated

Primary outcomes

  1. Number of Participants Who Discontinued the Use of Study Drug

    Time frame: 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.

  2. Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen

    Time frame: 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.

  3. Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen

    Time frame: 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.

  4. Duration of Treatment of Study Drug on a Prophylaxis Regimen

    Time frame: 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.

  5. Duration of Treatment of Study Drug an On-Demand Regimen

    Time frame: 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.

  6. Dose Per Administration of Study Drug on a Prophylaxis Regimen

    Time frame: 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.

  7. Dose Per Administration of Study Drug an On-Demand Regimen

    Time frame: 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.

  8. Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen

    Time frame: 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.

  9. Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen

    Time frame: 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.

  10. Hemostatic Effectiveness of Study Drug on an On-Demand Regimen

    Time frame: 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 outcomes

  1. Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen

    Time frame: 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.

  2. Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 30, 2017
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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