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

NCT02634723 | Completed

• 1 other identifier: 061501
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

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

  Throughout the study period of 6 months

• 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 Outcomes (8)

• Number and type of bleeding episodes treated with ADVATE

  Throughout the study period of 6 months

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

  Throughout the study period of 6 months

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

  Throughout the study period of 6 months

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

  Throughout the study period of 6 months

• Total number of exposure days (EDs) to ADVATE

  Throughout the study period of 6 months

Study Arms (1)

Previously Untreated Patients (PUPs)

PUPs in China with Moderate to Severe Hemophilia A

Biological: Octocog alfa (recombinant human coagulation factor VIII)

Interventions

Octocog alfa (recombinant human coagulation factor VIII) BIOLOGICAL

Also known as: ADVATE, Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM

Previously Untreated Patients (PUPs)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (6)

Institute of Hematology and Oncology, Harbin The First Hospital

Harbin, Heilongjiang, 150070, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430074, China

Location

Nanjing Children's Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210019, China

Location

Shandong Blood Center

Jinan, Shandong, 250014, China

Location

Zhejiang Provincial Hospital of TCM/The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

Location

Related Links

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

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human; Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: December 23, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

CN (6)