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NCT03379974 · ClinicalTrials.gov registry record · Phase 4

Exercise Versus DDAVP in Patients With Mild Hemophilia A

A Phase 4 study, sponsored by Nationwide Children's Hospital.

Completed
Registry status
Phase 4
Development phase
32
Enrollment target

NCT03379974: Completed Phase 4 study, sponsored by Nationwide Children's Hospital.

NCT03379974 is a Phase 4 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03379974, a Phase 4 study, has completed, sponsored by Nationwide Children's Hospital.

COMPLETED
Registry status
Phase 4
Development phase
32 participants
Enrollment target

Study Summary

Individuals with mild hemophilia A (MHA) bleed infrequently but can in the setting of trauma which often is when participating in sports/exercise. Although both exercise and DDAVP (desmopressin) can raise Factor 8/Von Willebrand Factor (FVIII/VWF levels), it is not clear whether the pathophysiological mechanism is the same. Consequently it is not known if DDAVP and exercise would have additive effects in raising FVIII:C and VWF levels or if one would one negate the effect of the other. The aim of this 2 center (Sickkids and Nationwide Children's), prospective, cross-over design study is to compare the impact of exercise vs. DDAVP on hemostasis in patients with MHA and also to investigate the impact of sequentially administering these interventions on their hemostatic indices.

Primary Outcome

To compare the increase in FVIII:C (measured as absolute and fold increase) associated with a standardized moderate intensity aerobic exercise regimen (3-minutes of exercise at 85% of the predicted maximum heart rate) to intranasal DDAVP in post-adolescent males with MHA

Interventions

  • BEHAVIORAL Exercise Intervention
  • DRUG DDAVP Inhalant Product

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2018-07-31
Est. Completion 2019-12-05
Phase Phase 4
Nationwide Children's Hospital

188 total trials

What the finished NCT03379974 record still lists

NCT03379974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Exercise Intervention is the first listed.

NCT03379974 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03379974 about?

NCT03379974 is a clinical study titled "Exercise Versus DDAVP in Patients With Mild Hemophilia A". Individuals with mild hemophilia A (MHA) bleed infrequently but can in the setting of trauma which often is when participating in sports/exercise. Although both exercise and DDAVP (desmopressin) can raise Factor 8/Von Willebrand Factor (FVIII/VWF levels), it is not clear whether the pathophysiologic...

What is the current status of trial NCT03379974?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2018-07-31. Estimated completion is 2019-12-05.

What interventions are being tested in trial NCT03379974?

The interventions under investigation include: Exercise Intervention (BEHAVIORAL), DDAVP Inhalant Product (DRUG).

Who is sponsoring clinical trial NCT03379974?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03379974's enrollment target sits among peer trials

32 1534th of 2000 higher than 457 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03379974, the US trial registry maintained by the National Library of Medicine. NCT03379974 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.