Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00108758

Enrollment

Registered

2005-04-19

Start date

2004-03-31

Completion date

2005-11-30

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 Africa, Asia, Europe, South America, and the United States of America (USA). The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

Interventions

DRUGactivated recombinant human factor VII

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion criteria

* Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

Design outcomes

Primary

Measure	Time frame
Reduction of bleeds	During 3 months treatment period as compared to 3 months observation period

Secondary

Measure	Time frame
Efficacy variables	—

Countries

Argentina, Brazil, Bulgaria, France, Philippines, Poland, Romania, Russia, South Africa, Spain, Turkey (Türkiye), United States

Outcome results

None listed

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