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Completed

NCT Number: NCT02634723

Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A

The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.

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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

Institute of Hematology and Oncology, Harbin The First Hospital, Harbin, Heilongjiang, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously untreated patient (PUP) in China with moderate to severe hemophilia A.
  • Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A
  • Informed consent form from patient and/or legal representative will need to be signed per local regulation

Exclusion criteria

  • Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease
  • Participants who participated in another investigational FVIII drug study, or had participated in any clinical study involving an investigational FVIII drug during the course of the observation period

Treatment and study plan

Octocog alfa (recombinant human coagulation factor VIII)

Biological

Other names: ADVATE, Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM

Primary outcomes

  1. Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed

    Time frame: Throughout the study period of 6 months

  2. Number and type of other serious and non-serious adverse events (AEs)

    Time frame: Throughout the study period of 6 months

    Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors

Secondary outcomes

  1. Number and type of bleeding episodes treated with ADVATE

    Time frame: Throughout the study period of 6 months

  2. Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE

    Time frame: Throughout the study period of 6 months

  3. Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE

    Time frame: Throughout the study period of 6 months

  4. Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE

    Time frame: Throughout the study period of 6 months

  5. Total number of exposure days (EDs) to ADVATE

    Time frame: Throughout the study period of 6 months

  6. Total units of ADVATE administered

    Time frame: Throughout the study period of 6 months

  7. Total number of exposure days (EDs) to all Factor VIII (FVIII) products

    Time frame: Throughout the study period of 6 months

  8. Total units of all Factor VIII (FVIII) products administered

    Time frame: Throughout the study period of 6 months

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 18, 2015
Registry last updated
Mar 17, 2021

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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