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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:	NCT02250573
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 Haemophilia B Subjects Undergoing Surgery
Scientific title:	An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.
Date of first enrolment:	December 2005
Target sample size:
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02250573
Study type:	Interventional
Study design:	Primary purpose: Treatment.
Phase:	Phase 3

Countries of recruitment
Poland	Romania	Russian Federation

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with moderate to severe haemophilia B undergoing major surgery requiring an
in-patient stay of generally 5 to 10 days.

Exclusion Criteria:

-

Age minimum: N/A
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)

Incremental recovery for Factor IX [Time Frame: 90 min post-dose]

Secondary Outcome(s)

Secondary ID(s)

R9VFSUR

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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