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

March 16, 2021 updated by: Baxalta now part of Shire
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

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

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150070
        • Institute of Hematology and Oncology, Harbin The First Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430074
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210019
        • Nanjing Children's Hospital Affiliated to Nanjing Medical University
    • Shandong
      • Jinan, Shandong, China, 250014
        • Shandong Blood Center
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Zhejiang Provincial Hospital of TCM/The First Affiliated Hospital of Zhejiang Chinese Medical University

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previously untreated patients (PUPs) in China with moderate to severe hemophilia A.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease
  2. 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

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 Untreated Patients (PUPs)
PUPs in China with Moderate to Severe Hemophilia A
Biological: Octocog alfa (recombinant human coagulation factor VIII)
Other Names:
  • ADVATE
  • Recombinant antihemophilic factor
  • plasma/albumin-free method (rAHF-PFM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
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
Throughout the study period of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number and type of bleeding episodes treated with ADVATE
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
Total number of exposure days (EDs) to ADVATE
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
Total units of ADVATE administered
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
Total number of exposure days (EDs) to all Factor VIII (FVIII) products
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months
Total units of all Factor VIII (FVIII) products administered
Time Frame: Throughout the study period of 6 months
Throughout the study period of 6 months

Collaborators and Investigators

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

Sponsor

Baxalta now part of Shire

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)

December 23, 2015

Primary Completion (ACTUAL)

June 30, 2016

Study Completion (ACTUAL)

June 30, 2016

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (ESTIMATE)

December 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061501

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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