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

Hemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634723
• Other study ID #: 061501
• Status: Completed
• Start date: December 23, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: March 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• Octocog alfa (recombinant human coagulation factor VIII)

Locations

Country	Name	City	State
China	Zhejiang Provincial Hospital of TCM/The First Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang
China	Institute of Hematology and Oncology, Harbin The First Hospital	Harbin	Heilongjiang
China	Shandong Blood Center	Jinan	Shandong
China	Nanjing Children's Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed		Throughout the study period of 6 months
Primary	Number and type of other serious and non-serious adverse events (AEs)	Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors	Throughout the study period of 6 months
Secondary	Number and type of bleeding episodes treated with ADVATE		Throughout the study period of 6 months
Secondary	Number of bleeding episodes treated with 1, 2, 3, = 4 infusions of ADVATE		Throughout the study period of 6 months
Secondary	Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE		Throughout the study period of 6 months
Secondary	Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE		Throughout the study period of 6 months
Secondary	Total number of exposure days (EDs) to ADVATE		Throughout the study period of 6 months
Secondary	Total units of ADVATE administered		Throughout the study period of 6 months
Secondary	Total number of exposure days (EDs) to all Factor VIII (FVIII) products		Throughout the study period of 6 months
Secondary	Total units of all Factor VIII (FVIII) products administered		Throughout the study period of 6 months

External Links

•   To obtain more information on the study, click here/on this link.