TG-INSIGHT With Joint POCUS, Hemostatic Potential in Patients With Severe Hemophilia A on Novel Replacement and Substitution FVIII Therapies

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07692217
Status
Not Yet Recruiting

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Conditions

  • Factor VIII (FVIII)
  • Hemophilia A

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Half-life factor VIII based replacement therapy — DRUG
    Children with moderate or severe hemophilia A being treated with prophylactic extended half-life factor VIII based replacement therapy (such as Altuviiio) as part of their hemophilia treatment to prevent spontaneous joint bleeds.
  • Non-FVIII based replacement therapy — DRUG
    Children with moderate or severe hemophilia A being treated with non-FVIII based replacement therapy (such as Hemlibra) as part of their hemophilia treatment to prevent spontaneous joint bleeds.

Study Details

This is an observational research study to find out if there is a difference in the way children with moderate or severe hemophilia A, treated on two different types of factor replacement, form a clot and also evaluate if they develop tiny bleeds within the joint and subsequently early joint changes when receiving extended half-life factor VIII.

Key Dates

First listed
Jul 9, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
May 31, 2033
Completion
May 31, 2033

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Participants with hemophilia A
    The study plans to recruit participants with severe (FVIII \<1%) and moderate (FVIII 1-4%) HA.

Primary Outcome Measure

Thrombin Generation [ Time Frame: Thrombin generation assay will be measured at 5 time points within a week of receiving dose of medication ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Southwestern Medical CenterDallasTexas75235
Jessica Garcia, MD
[email protected]
214-456-7000
Jessica Garcia, MD (PRINCIPAL_INVESTIGATOR)
Guy Young, MD (SUB_INVESTIGATOR)
Ayesha Zia, MD (SUB_INVESTIGATOR)

Find similar trials in Dallas, TX

By research site
The University of Texas Southwestern Medical Center· Dallas, TX

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