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ADYNOVATE Drug Use-Results Survey

Sponsor
Shire (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03169972
Collaborator
Takeda (Industry)
145
Enrollment
52
Locations
69.7
Anticipated Duration (Months)
2.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: ADYNOVATE

Study Design

Study Type:
Observational
Anticipated Enrollment :
145 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
ADYNOVATE Drug Use-Results Survey
Actual Study Start Date :
Apr 12, 2017
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Participants who discontinued the use of ADYNOVATE - previously treated patients (PTPs) [Throughout the study participation period: 1 year for previously treated patients (PTPs)]

      Number of PTPs who discontinued the use of ADYNOVATE

    2. Participants who discontinued the use of ADYNOVATE - previously untreated patients (PUPs) [Throughout the study participation period: 2 years for previously untreated patients (PUPs)]

      Number of PUPs who discontinued the use of ADYNOVATE

    3. Participants who developed a Factor VIII (FVIII) inhibitor - previously treated patients (PTPs) [Throughout the study participation period: 1 year for previously treated patients (PTPs)]

      Number of PTPs who developed a Factor VIII (FVIII) inhibitor

    4. Participants who developed a Factor VIII (FVIII) inhibitor - previously untreated patients (PUPs) [Throughout the study participation period: 2 years for previously untreated patients (PUPs)]

      Number of PUPs who developed a Factor VIII (FVIII) inhibitor

    5. Annual bleed rate (ABR) - previously treated patients (PTPs) [Throughout the study participation period: 1 year for previously treated patients (PTPs)]

      Annual bleed rate (ABR) of PTPs on a prophylaxis regimen

    6. Annual bleed rate (ABR) - previously untreated patients (PUPs) [Throughout the study participation period: 2 years for previously untreated patients (PUPs)]

      Annual bleed rate (ABR) of PUPs on a prophylaxis regimen

    7. Doses to treat a bleed of participants on an on-demand regimen - previously treated patients (PTPs) [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

    8. Doses to treat a bleed of participants on an on-demand regimen - previously untreated patients (PUPs) [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

    9. Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously treated patients (PTPs) [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)

    10. Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously untreated patients (PUPs) [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)

    Secondary Outcome Measures

    1. Participants who experience shock or anaphylaxis - previously treated patients (PTPs) [Throughout the study participation period: 1 year for previously treated patients (PTPs)]

      Number of PTPs who experience shock or anaphylaxis

    2. Participants who experience shock or anaphylaxis - previously untreated patients (PUPs) [Throughout the study participation period: 2 years for previously untreated patients (PUPs)]

      Number of PUPs who experience shock or anaphylaxis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagoya City, Japan Nagoya City Aichi Prefecture Japan 466-8560
    2 Hirosaki City Hirosaki City Aomori Prefecture Japan 036-8004
    3 Chiba-City, Japan Chiba-City Chiba Prefecture Japan 260-8677
    4 Matsudo City, Japan Matsudo City Chiba Prefecture Japan 271-8511
    5 Narita City Narita City Chiba Prefecture Japan 286-8523
    6 Matsuyama City, Japan Matsuyama City Ehime Prefecture Japan 790-8524
    7 Toon City Toon City Ehime Prefecture Japan 791-0295
    8 Fukuoka-City, Japan Fukuoka-City Fukuoka Prefecture Japan 812-8582
    9 Kitakyusyu City, Japan Kitakyusyu City Fukuoka Prefecture Japan 805-0050
    10 Kitakyusyu City, Japan Kitakyusyu City Fukuoka Prefecture Japan 807-8556
    11 Koriyama City Koriyama City Fukushima Prefecture Japan 963-8585
    12 Sukagawa City Sukagawa City Fukushima Prefecture Japan 962-8507
    13 Ogaki City, Japan Ogaki City Gifu Prefecture Japan 503-8502
    14 Maebashi City Maebashi City Gunma Prefecture Japan 371-8511
    15 Hiroshima City, Japan Hiroshima City Hiroshima Prefecture Japan 734-8551
    16 Kudou-Gun, Japan Kudou-Gun Hokkaido Japan 049-4501
    17 Sapporo City Sapporo City Hokkaido Japan 060-8648
    18 Kobe City Kobe City Hyogo Prefecture Japan 650-0047
    19 Kobe City Kobe City Hyogo Prefecture Japan 651-2273
    20 Nishinomiya City, Japan Nishinomiya City Hyogo Prefecture Japan 633-8501
    21 Morioka City, Japan Morioka City Iwate Prefecture Japan 020-8560
    22 Zentuji City, Japan Zentuji City Kagawa Prefecture Japan 765-8501
    23 Kagoshima City, Japan Kagoshima City Kagoshima Prefecture Japan 890-0046
    24 Kawasaki City, Japan Kawasaki City Kanagawa Prefecture Japan 216-8511
    25 Yokohama City, Japan Yokohama City Kanagawa Prefecture Japan 232-8555
    26 Yokohama City, Japan Yokohama City Kanagawa Prefecture Japan 241-0811
    27 Koti City, Japan Koti City Koti Prefecture Japan 781-8555
    28 Minamata City, Japan Minamata City Kumamoto Prefecture Japan 867-0041
    29 Kyoto City Kyoto City Kyoto Prefecture Japan 605-0981
    30 Tsu City, Japan Tsu City Mie Prefecture Japan 514-8507
    31 Sendai City Sendai City Miyagi Prefecture Japan 983-8520
    32 Tome City, Japan Tome City Miyagi Prefecture Japan 987-0511
    33 Nichinan City Nichinan City Miyazaki Prefecture Japan 887-0013
    34 Matsumoto City Matsumoto City Nagano Prefecture Japan 390-8621
    35 Nagano City, Japan Nagano City Nagano Prefecture Japan 380-0928
    36 Jyoetsu City Jyoetsu City Niigata Prefecture Japan 943-0147
    37 Kashiwazaki City Kashiwazaki City Niigata Prefecture Japan 945-0035
    38 Kurasiki City, Japan Kurasiki City Okayama Prefecture Japan 701-0192
    39 Okayama City, Japan Okayama City Okayama Prefecture Japan 700-8558
    40 Higashiosaka City Higashiosaka City Osaka Prefecture Japan 578-8588
    41 Hirakata City Hirakata City Osaka Prefecture Japan 573-1191
    42 Nishi-ku Nishi-ku Osaka Prefecture Japan 593-8304
    43 Osaka City, Japan Osaka City Osaka Prefecture Japan 540-0006
    44 Osaka-City, Japan Osaka-City Osaka Prefecture Japan 554-0012
    45 Koshigaya City, Japan Koshigaya City Saitama Prefecture Japan 343-8555
    46 Saitama-City, Japan Saitama-City Saitama Prefecture Japan 330-8777
    47 Tokushima City, Japan Tokushima City Tokushima Prefecture Japan 770-8503
    48 Shinjuku-Ku, Japan Shinjuku-Ku Tokyo Metropolis Japan 160-0023
    49 Setagaya-ku, Japan Setagaya-ku Tokyo Metropolitan Japan 157-8535
    50 Suginami-ku, Japan Suginami-ku Tokyo Japan 167-0035
    51 Sakata City, Japan Sakata City Yamagata Prefecture Japan 998-8501
    52 Shunan City, Japan Shunan City Yamagata Prefecture Japan 745-8522

    Sponsors and Collaborators

    • Shire
    • Takeda

    Investigators

    • Study Director: Study Director, Shire

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT03169972
    Other Study ID Numbers:
    • 261601
    First Posted:
    May 30, 2017
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemophilia A
    Factor VIII
    BAX 855

    Study Results

    No Results Posted as of Mar 3, 2022