MedTrace Logo

Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A

NCT01863758 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-01-30

Study results available
· View outcomes & findings →

Summary

To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Human-cl rhFVIII as on demand treatment.

Conditions

  • Severe Haemophilia A

Interventions

BIOLOGICAL

Human-cl rhFVIII

Human-cl rhFVIII was provided as a freeze-dried concentrate to be reconstituted in water for injection.

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Austria
  • Bulgaria
  • Germany
  • Hungary
  • Poland
  • Romania
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

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 NCT01863758 on ClinicalTrials.gov