Trial | NCT02231944  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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
Study Started
Jul 31
1997
Primary Completion
Oct 31
2003
Last Update
Feb 22
2018

Biological Replenine®-VF (High Purity Factor IX)

Replenine®-VF Experimental

Criteria 

Inclusion Criteria:

Previously treated patients
At least 12 years of age
Severe Haemophilia B and without inhibitor to factor IX

Exclusion Criteria:

-
No Results Posted