Newark, New Jersey 07112

  • Haemophilia B With Inhibitors

Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

F7HAEM-1505


NCT ID:

NCT00108758


Secondary ID:


Study Acronym:


Brief Title:

Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

2 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novo Nordisk A/S


Oversight Authority:

  • Bulgaria: Ministry of Health
  • Spain: Spanish Agency of Medicines
  • Russia: Pharmacological Committee, Ministry of Health
  • Turkey: Ministry of Health
  • Brazil: National Health Surveillance Agency
  • Poland: Ministry of Health
  • Romania: State Institute for Drug Control
  • South Africa: Medicines Control Council
  • Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
  • Philippines: Bureau of Food and Drugs
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

23


Enrollment Type:

Actual


Overall Contact Information

Official Name:Global Clinical Registry (GCR, 1452)
Study Director
Novo Nordisk A/S

Study Dates

Start Date:March 2004
Completion Date:November 2005
Completion Type:Actual
Primary Completion Date:November 2005
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 11, 2017
First Received Date:April 18, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reduction of bleeds
Time Frame:During 3 months treatment period as compared to 3 months observation period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Efficacy variables
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:activated recombinant human factor VII

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novo Nordisk A/S

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13.
PMID:17723130

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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