MedTrace Logo

Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A

NCT00717626 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-10-08

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to test the feasibility of a large-scale clinical trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy outcomes so that we can better plan a large-scale study; we will estimate the effect size and variability of effect and resource utilization of once-daily prophylaxis to allow us to set a sample size for a definitive trial.

Conditions

Interventions

DRUG

Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS

Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is \< 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Brian Feldman, MD,MSc,FRCPC · The Hospital for Sick Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00717626 on ClinicalTrials.gov