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An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

NCT02231944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-02-22

No results posted yet for this study

Summary

To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.

To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

Conditions

  • Haemophilia B

Interventions

BIOLOGICAL

Replenine®-VF (High Purity Factor IX)

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Study Design

Purpose
TREATMENT

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-07-31
Primary Completion
2003-10-31

Countries

  • Poland
  • United Kingdom

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 NCT02231944 on ClinicalTrials.gov