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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02231944
Date of registration:	02/09/2014
Prospective Registration:	No
Primary sponsor:	Bio Products Laboratory
Public title:	An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients
Scientific title:	An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.
Date of first enrolment:	July 1997
Target sample size:
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02231944
Study type:	Interventional
Study design:	Primary purpose: Treatment.
Phase:	Phase 3

Countries of recruitment
Poland	United Kingdom

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Previously treated patients

- At least 12 years of age

- Severe Haemophilia B and without inhibitor to factor IX

Exclusion Criteria:

-

Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Haemophilia B

Intervention(s)

Biological: Replenine®-VF (High Purity Factor IX)

Primary Outcome(s)

Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later. [Time Frame: Baseline and 3 months post-baseline.]

Secondary Outcome(s)

Secondary ID(s)

R9VFSE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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