Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

Novo Nordisk A/S23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Interventions

activated recombinant human factor VIIDRUG

Eligibility

Sex: MALEMin age: 2 Years

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

Reduction of bleeds

Time frame: During 3 months treatment period as compared to 3 months observation period

Secondary Outcomes

Efficacy variables

Data from ClinicalTrials.gov

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