ADYNOVATE Drug Use-Results Survey

December 13, 2023 updated by: Takeda

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi Prefecture
      • Nagoya City, Aichi Prefecture, Japan, 466-8560
        • Nagoya City, Japan
    • Aomori Prefecture
      • Hirosaki City, Aomori Prefecture, Japan, 036-8004
        • Hirosaki City
    • Chiba Prefecture
      • Chiba-City, Chiba Prefecture, Japan, 260-8677
        • Chiba-City, Japan
      • Matsudo City, Chiba Prefecture, Japan, 271-8511
        • Matsudo City, Japan
      • Narita City, Chiba Prefecture, Japan, 286-8523
        • Narita City
    • Ehime Prefecture
      • Matsuyama City, Ehime Prefecture, Japan, 790-8524
        • Matsuyama City, Japan
      • Toon City, Ehime Prefecture, Japan, 791-0295
        • Toon City
    • Fukuoka Prefecture
      • Fukuoka-City, Fukuoka Prefecture, Japan, 812-8582
        • Fukuoka-City, Japan
      • Kitakyusyu City, Fukuoka Prefecture, Japan, 805-0050
        • Kitakyusyu City, Japan
      • Kitakyusyu City, Fukuoka Prefecture, Japan, 807-8556
        • Kitakyusyu City, Japan
    • Fukushima Prefecture
      • Koriyama City, Fukushima Prefecture, Japan, 963-8585
        • Koriyama City
      • Sukagawa City, Fukushima Prefecture, Japan, 962-8507
        • Sukagawa City
    • Gifu Prefecture
      • Ogaki City, Gifu Prefecture, Japan, 503-8502
        • Ogaki City, Japan
    • Gunma Prefecture
      • Maebashi City, Gunma Prefecture, Japan, 371-8511
        • Maebashi City
    • Hiroshima Prefecture
      • Hiroshima City, Hiroshima Prefecture, Japan, 734-8551
        • Hiroshima City, Japan
    • Hokkaido
      • Kudou-Gun, Hokkaido, Japan, 049-4501
        • Kudou-Gun, Japan
      • Sapporo City, Hokkaido, Japan, 060-8648
        • Sapporo City
    • Hyogo Prefecture
      • Kobe City, Hyogo Prefecture, Japan, 650-0047
        • Kobe City
      • Kobe City, Hyogo Prefecture, Japan, 651-2273
        • Kobe City
      • Nishinomiya City, Hyogo Prefecture, Japan, 633-8501
        • Nishinomiya City, Japan
    • Iwate Prefecture
      • Morioka City, Iwate Prefecture, Japan, 020-8560
        • Morioka City, Japan
    • Kagawa Prefecture
      • Zentuji City, Kagawa Prefecture, Japan, 765-8501
        • Zentuji City, Japan
    • Kagoshima Prefecture
      • Kagoshima City, Kagoshima Prefecture, Japan, 890-0046
        • Kagoshima City, Japan
    • Kanagawa Prefecture
      • Kawasaki City, Kanagawa Prefecture, Japan, 216-8511
        • Kawasaki City, Japan
      • Yokohama City, Kanagawa Prefecture, Japan, 232-8555
        • Yokohama City, Japan
      • Yokohama City, Kanagawa Prefecture, Japan, 241-0811
        • Yokohama City, Japan
    • Koti Prefecture
      • Koti City, Koti Prefecture, Japan, 781-8555
        • Koti City, Japan
    • Kumamoto Prefecture
      • Minamata City, Kumamoto Prefecture, Japan, 867-0041
        • Minamata City, Japan
    • Kyoto Prefecture
      • Kyoto City, Kyoto Prefecture, Japan, 605-0981
        • Kyoto City
    • Mie Prefecture
      • Tsu City, Mie Prefecture, Japan, 514-8507
        • Tsu City, Japan
    • Miyagi Prefecture
      • Sendai City, Miyagi Prefecture, Japan, 983-8520
        • Sendai City
      • Tome City, Miyagi Prefecture, Japan, 987-0511
        • Tome City, Japan
    • Miyazaki Prefecture
      • Nichinan City, Miyazaki Prefecture, Japan, 887-0013
        • Nichinan City
    • Nagano Prefecture
      • Matsumoto City, Nagano Prefecture, Japan, 390-8621
        • Matsumoto City
      • Nagano City, Nagano Prefecture, Japan, 380-0928
        • Nagano City, Japan
    • Niigata Prefecture
      • Jyoetsu City, Niigata Prefecture, Japan, 943-0147
        • Jyoetsu City
      • Kashiwazaki City, Niigata Prefecture, Japan, 945-0035
        • Kashiwazaki City
    • Okayama Prefecture
      • Kurasiki City, Okayama Prefecture, Japan, 701-0192
        • Kurasiki City, Japan
      • Okayama City, Okayama Prefecture, Japan, 700-8558
        • Okayama City, Japan
    • Osaka Prefecture
      • Higashiosaka City, Osaka Prefecture, Japan, 578-8588
        • Higashiosaka City
      • Hirakata City, Osaka Prefecture, Japan, 573-1191
        • Hirakata City
      • Nishi-ku, Osaka Prefecture, Japan, 593-8304
        • Nishi-ku
      • Osaka City, Osaka Prefecture, Japan, 540-0006
        • Osaka City, Japan
      • Osaka-City, Osaka Prefecture, Japan, 554-0012
        • Osaka-City, Japan
    • Saitama Prefecture
      • Koshigaya City, Saitama Prefecture, Japan, 343-8555
        • Koshigaya City, Japan
      • Saitama-City, Saitama Prefecture, Japan, 330-8777
        • Saitama-City, Japan
    • Tokushima Prefecture
      • Tokushima City, Tokushima Prefecture, Japan, 770-8503
        • Tokushima City, Japan
    • Tokyo
      • Suginami-ku, Tokyo, Japan, 167-0035
        • Suginami-ku, Japan
    • Tokyo Metropolis
      • Shinjuku-Ku, Tokyo Metropolis, Japan, 160-0023
        • Shinjuku-Ku, Japan
    • Tokyo Metropolitan
      • Setagaya-ku, Tokyo Metropolitan, Japan, 157-8535
        • Setagaya-ku, Japan
    • Yamagata Prefecture
      • Sakata City, Yamagata Prefecture, Japan, 998-8501
        • Sakata City, Japan
      • Shunan City, Yamagata Prefecture, Japan, 745-8522
        • Shunan City, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hemophilia A (congenital blood coagulation factor VIII deficiency) who receive ADYNOVATE

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Previously treated patients (PTPs)
PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products
Biological: ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated
Other Names:
  • BAX 855
  • BAX855
  • Recombinant Factor VIII (FVIII) PEGylated
Previously untreated patients (PUPs)
PUPs: patients who had 3 or less previous exposure days to other products
Biological: ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated
Other Names:
  • BAX 855
  • BAX855
  • Recombinant Factor VIII (FVIII) PEGylated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants who discontinued the use of ADYNOVATE - previously treated patients (PTPs)
Time Frame: Throughout the study participation period: 1 year for 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)
Participants who discontinued the use of ADYNOVATE - previously untreated patients (PUPs)
Time Frame: Throughout the study participation period: 2 years for 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)
Participants who developed a Factor VIII (FVIII) inhibitor - previously treated patients (PTPs)
Time Frame: Throughout the study participation period: 1 year for 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)
Participants who developed a Factor VIII (FVIII) inhibitor - previously untreated patients (PUPs)
Time Frame: Throughout the study participation period: 2 years for 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)
Annual bleed rate (ABR) - previously treated patients (PTPs)
Time Frame: Throughout the study participation period: 1 year for 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)
Annual bleed rate (ABR) - previously untreated patients (PUPs)
Time Frame: Throughout the study participation period: 2 years for 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)
Doses to treat a bleed of participants on an on-demand regimen - previously treated patients (PTPs)
Time Frame: At bleed resolution throughout the study participation period: 1 year for 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)
Doses to treat a bleed of participants on an on-demand regimen - previously untreated patients (PUPs)
Time Frame: At bleed resolution throughout the study participation period: 2 years for 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).
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously treated patients (PTPs)
Time Frame: At bleed resolution throughout the study participation period: 1 year for 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)
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously untreated patients (PUPs)
Time Frame: At bleed resolution throughout the study participation period: 2 years for 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants who experience shock or anaphylaxis - previously treated patients (PTPs)
Time Frame: Throughout the study participation period: 1 year for previously treated patients (PTPs)
Number of PTPs who experience shock or anaphylaxis
Throughout the study participation period: 1 year for previously treated patients (PTPs)
Participants who experience shock or anaphylaxis - previously untreated patients (PUPs)
Time Frame: Throughout the study participation period: 2 years for previously untreated patients (PUPs)
Number of PUPs who experience shock or anaphylaxis
Throughout the study participation period: 2 years for previously untreated patients (PUPs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Collaborators

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2017

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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