MedTrace Logo

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

NCT01392547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-05-15

Study results available
· View outcomes & findings →

Summary

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Conditions

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

Interventions

DRUG

vatreptacog alfa (activated)

1-3 doses per bleeding episode

DRUG

eptacog alfa (activated)

1-3 doses per bleeding episode

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Austria
  • Brazil
  • Croatia
  • Greece
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT01392547 on ClinicalTrials.gov