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

NCT02256917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-01-19

Study results available
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Summary

The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.

Conditions

  • Severe Haemophilia A

Interventions

BIOLOGICAL

Human cl rhFVIII

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Craig M Kessler, MD · Georgetown University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States
  • Canada
  • Croatia
  • Finland
  • France
  • Japan
  • Netherlands
  • North Macedonia
  • Slovenia

Study Locations

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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 NCT02256917 on ClinicalTrials.gov