Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07692217

Conditions

Hemophilia A

Factor VIII (FVIII)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Half-life factor VIII based replacement therapy

Non-FVIII based replacement therapy

Study Details

Brief summary:

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.

Conditions

Hemophilia A

Factor VIII (FVIII)

Study ID

NCT07692217

Start date

Jul 22, 2026

Status verified date

Sep, 2026

Completion date

May, 2033

Anticipated

Primary completion date

May, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants with moderate or severe HA who are on prophylaxis with either weekly, biweekly, or every 4-weeks emicizumab or weekly efanesoctocog alfa for at least 2 months.
  • >6 months of age

Exclusion Criteria:

  • Participants with active FVIII inhibitor (>0.5 BU/mL)
  • Presence of an additional bleeding disorder other than hemophilia A

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with hemophilia A

The study plans to recruit participants with severe (FVIII <1%) and moderate (FVIII 1-4%) HA.

Interventions

Half-life factor VIII based replacement therapy

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

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.

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 ]
  • Hemophilia Joint Health Score [ Time Frame: Obtained at baseline and every 6 months, until 3 years ]

Central Contacts and Locations

Central contacts

Jessica Garcia, MD

214-456-7000Jessica.Garcia@UTSouthwestern.edu

Locations

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Jessica Garcia, MD

214-456-7000Jessica.Garcia@UTSouthwestern.edu

Principal Investigator:

Jessica Garcia, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.