NCT07101224

Brief Summary

This is an open-label, prospective, multi-center, patient registry in Chinese Hemophilia A and B patients treated with anti-hemophilic coagulation factor replacement therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
6.1 years until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
Last Updated

August 3, 2025

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

May 26, 2017

Last Update Submit

August 1, 2025

Conditions

Hemophilia AHemophilia B

Keywords

anti-hemophilic coagulation factor replacement therapy

Outcome Measures

Primary Outcomes (1)

  • The incidence of MIEs and other SAEs

    The incidence of MIE(medically important events)s and other SAE(serious adverse event)s in the anti-hemophilic replacement treatment

    at the end of 2 year data registry

Secondary Outcomes (1)

  • Treatment regimen

    at the end of 2 year data registry

Study Arms (2)

Hemophilia A

Hemophilia B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosed Hemophilia A and Hemophilia B patient with anti-hemophilic coagulation factor replacement therapy will be selected.

You may qualify if:

  • Hemophilia A and Hemophilia B patient diagnosed;
  • Taking anti-hemophilic coagulation factor replacement therapy during the 2 year registry period.

You may not qualify if:

  • \. Unwilling or unable to follow the terms of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Blood disease

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2017

First Posted

August 3, 2025

Study Start

May 7, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 3, 2025

Record last verified: 2024-05

Locations

CN(1)