Trial of NovoSeven® in Haemophilia - Joint Bleeds

NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Doses of NovoSeven® and Open-Label FEIBA®

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00108797

Enrollment

Registered

2005-04-19

Start date

2001-09-30

Completion date

2006-02-28

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Brief summary

This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.

Interventions

DRUGeptacog alfa (activated)

DRUGFeiba VH

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

No minimum to 20 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively

Design outcomes

Primary

Measure	Time frame
Comparison with FEIBA on review of pain, joint mobility and circumference	after 1, 3, 6, and 9 hours of treatment, respectively

Secondary

Measure	Time frame
Safety variables	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026