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OpenTrials
Completed

NCT Number: NCT03824522

Post Marketing Surveillance Study for ADYNOVATE in South Korea

The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how effective ADYNOVATE is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries.

Participants with hemophilia A who will be newly prescribed with ADYNOVATE treatment or have already been taking ADYNOVATE treatment according to the physician's decision will be included in this study.

Participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.

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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

Daegu Catholic University Medical Center, Daegu, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participants with a diagnosis of hemophilia A who will be newly prescribed with ADYNOVATE or already have been prescribed ADYNOVATE according to the study physician's judgment shall be included in this study if:

  • The participant or legally authorized representative has given written informed consent to participate in the study.
  • The participant is indicated for treatment according to the ADYNOVATE South Korea prescribing information (PI).

Exclusion criteria

Participants should be excluded from this study if:

  • The participant or legally authorized representative does not wish to participate in the study.
  • Any of the contraindications included in the PI for ADYNOVATE apply.
  • Participant is enrolled in an interventional trial using an investigational product other than ADYNOVATE.

Treatment and study plan

ADYNOVATE

Biological

Pegylated recombinant human factor VIII

Other names: PEGylated rFVIII

Primary outcomes

  1. Incidence of adverse events

    Time frame: Throughout the duration of patient participation of up to approximately 6 months

    Serious adverse events and non-serious adverse events

  2. Frequency of adverse events

    Time frame: Throughout the duration of patient participation of up to approximately 6 months

    Serious adverse events and non-serious adverse events

Secondary outcomes

  1. Incidence of inhibitor titers for FVIII antibodies

    Time frame: Throughout the duration of patient participation of up to approximately 6 months

    By titer levels, high and lower titer categories

  2. Number of treated bleeds

    Time frame: Throughout the duration of patient participation of up to approximately 6 months

    Number of treated bleeds throughout the study period

  3. ADYNOVATE units required for bleed resolution

    Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months

    Number of ADYNOVATE units required for bleed resolution

  4. Number of ADYNOVATE infusions needed for the treatment of bleeding episodes

    Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months

    The number of ADYNOVATE infusions needed for each bleeding episode is determined by the participant, his/her caregiver, and/or clinician treating the participant, and is based upon the participant's response to treatment

  5. Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment

    Time frame: Throughout the duration of patient participation of up to approximately 6 months

    Using a 4-point ordinal scale (Excellent, Good, Fair, or None)

  6. Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen

    Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months

    Using a 4-point ordinal scale (Excellent, Good, Fair, or None)

  7. Assessment of perioperative effectiveness of ADYNOVATE

    Time frame: Throughout the duration of patient participation of up to approximately 6 months

    Using a 4-point ordinal scale (Excellent, Good, Fair, or None)

  8. Clinically significant changes in laboratory results

    Time frame: Throughout the duration of patient participation of up to approximately 6 months

    Number of clinically significant changes in laboratory results

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Collaborators

  • Takeda Pharma Korea Co. Ltd.

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2019
Registry last updated
Feb 26, 2024

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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