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Hemostatic Agent

DDAVP vs. Exercise in Patients With Mild Hemophilia A

Phase 4

Waitlist Available

Led By Manuel Carcao

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 30 min post intervention #1, 30 min post intervention#2 and 90 minute post intervention#2

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

All Individual Drugs Already Approved

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 Columbus, Ohio), 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.

Eligible Conditions

Hemophilia A

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 min post intervention #1, 30 min post intervention#2 and 90 minute post intervention#2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 30 min post intervention #1, 30 min post intervention#2 and 90 minute post intervention#2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 min post intervention #1, 30 min post intervention#2 and 90 minute post intervention#2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Factor 8 level after exercise

Secondary study objectives

Associations between baseline physical activity scores and Factor 8 levels after exercise

Factor 8 level after sequential administration of exercise followed by IN DDAVP (or vice versa)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: Exercise aloneExperimental Treatment1 Intervention

Intervention #1: Exercise Intervention #2: no further intervention (rest)

Group II: Arm A: DDAVP followed by exerciseExperimental Treatment2 Interventions

Intervention #1: DDAVP. The participant will take either 1 or 2 nasal sprays of IN DDAVP. For patients weighing \<50 kg: 150 ug (i.e. 1 spray into one nostril) and patients weighing ≥50 kg: 300 ug (i.e. 2 sprays - one into each nostril). Intervention #2: Exercise

Group III: ARM D: Exercise followed by DDAVPExperimental Treatment2 Interventions

Intervention #1: Exercise Intervention #2: DDAVP. The participant will take either 1 or 2 nasal sprays of IN DDAVP. For patients weighing \<50 kg: 150 ug (i.e. 1 spray into one nostril) and patients weighing ≥50 kg: 300 ug (i.e. 2 sprays - one into each nostril).

Group IV: Arm B: DDAVP aloneActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Desmopressin

FDA approved

Exercise

2016

Completed Phase 1

~820

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