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A Post Marketing Surveillance Study for ADYNOVATE in South Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03824522
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
The purpose of this study is to characterize the safety and describe hemostatic effectiveness in patients receiving ADYNOVATE in routine clinical practice.

Condition or disease Intervention/treatment
Hemophilia A Biological: ADYNOVATE

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance Study for ADYNOVATE in South Korea
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Group/Cohort Intervention/treatment
All Study Participants
All participants enrolled will be treated with ADYNOVATE for hemophilia A at the time of enrollment according to a regimen determined by the study site treating physician/investigator.
Biological: ADYNOVATE
Pegylated recombinant human factor VIII
Other Name: PEGylated rFVIII




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Throughout the duration of patient participation of 6 months. Entire study period will be 72 months. ]
    Serious adverse events and non-serious adverse events

  2. Frequency of adverse events [ Time Frame: Throughout the duration of patient participation of 6 months. Entire study period will be 72 months. ]
    Serious adverse events and non-serious adverse events


Secondary Outcome Measures :
  1. Incidence of inhibitor titers for FVIII antibodies [ Time Frame: Throughout the duration of patient participation of 6 months. Entire study period will be 72 months. ]
    By titer levels, high and lower titer categories

  2. Number of treated bleeds [ Time Frame: Throughout the duration of patient participation of 6 months. Entire study period will be 72 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 6 months. Entire study period will be 72 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 6 months. Entire study period will be 72 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 6 months. Entire study period will be 72 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 6 months. Entire study period will be 72 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 6 months. Entire study period will be 72 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 6 months. Entire study period will be 72 months. ]
    Number of clinically significant changes in laboratory results



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemophilia A patients in South Korea who have been prescribed ADYNOVATE.
Criteria

Inclusion Criteria

Participants with a diagnosis of hemophilia A who have been prescribed ADYNOVATE according to the investigator'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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824522


Contacts
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Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

Locations
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Korea, Republic of
Severance Hospital Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: Site Contact    +82-10-3740-9149    CJ@yuhs.ac   
Principal Investigator: Chuhl Joo Lyu, Ph.D         
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 05278
Contact: Site Contact    +82-10-4618-3918    pysmd@khnmc.or.kr   
Principal Investigator: YoungShil Park, Ph.D         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 44033
Contact: Site Contact    +82-10-9709-9256    sang@uuh.ulsan.kr   
Principal Investigator: Sang Kyun Park, Ph.D         
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03824522     History of Changes
Other Study ID Numbers: 261603
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. 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.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
BAX 855
Factor VIII
Coagulants