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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-23

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Previously Untreated Patients (PUPs)

PUPs in China with Moderate to Severe Hemophilia A

Octocog alfa (recombinant human coagulation factor VIII)

Intervention Type BIOLOGICAL

Interventions

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Octocog alfa (recombinant human coagulation factor VIII)

Intervention Type BIOLOGICAL

Other Intervention Names

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ADVATE Recombinant antihemophilic factor plasma/albumin-free method (rAHF-PFM

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No