CClinicalTrials.gg
Sign In
CompletedNCT02634723Updated Mar 17, 2021

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

An observational study in Hemophilia A, sponsored by Baxalta now part of Shire. Completed at 6 sites in China. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Baxalta now part of Shire · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
21
Sex
All
01

Study 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.

02

Conditions studied

  • Hemophilia A

Browse trials for

03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's enrollment of 21 is below the median of 80 across 314 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Baxalta now part of Shire is the lead sponsor of 110 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
21 participants (actual)

Groups and cohorts

  • Previously Untreated Patients (PUPs)

    PUPs in China with Moderate to Severe Hemophilia A

    Biological: Octocog alfa (recombinant human coagulation factor VIII)

Interventions

  • BiologicalOctocog alfa (recombinant human coagulation factor VIII)

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

06

What researchers measure

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)

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

    Time frame: Throughout the study period of 6 months

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

07

Study locations

6 sites
  • Institute of Hematology and Oncology, Harbin The First Hospital
    Harbin, Heilongjiang 150070, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450000, China
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology
    Wuhan, Hubei 430074, China
  • Nanjing Children's Hospital Affiliated to Nanjing Medical University
    Nanjing, Jiangsu 210019, China
  • Shandong Blood Center
    Jinan, Shandong 250014, China
  • Zhejiang Provincial Hospital of TCM/The First Affiliated Hospital of Zhejiang Chinese Medical University
    Hangzhou, Zhejiang 310006, China
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02634723
Lead sponsor
Baxalta now part of Shire
Responsible party
Sponsor
First posted
Dec 18, 2015
Start date
Dec 23, 2015
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016
Last update
Mar 17, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hemophilia A→

Other studies from this sponsor

Baxalta now part of Shire

Start the discussion