An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery

NCT02250573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-02-22

No results posted yet for this study

Summary

The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.

Conditions

  • Haemophilia B

Interventions

BIOLOGICAL

Replenine®-VF (High Purity Factor IX)

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2006-04-30

Countries

  • Poland
  • Romania
  • Russia

Study Locations

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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 NCT02250573 on ClinicalTrials.gov