ICTRP Search Portal

Main

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:	19 February 2015
Main ID:	NCT02263469
Date of registration:	02/09/2014
Prospective Registration:	No
Primary sponsor:	Bio Products Laboratory
Public title:	A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years
Scientific title:	An Open Multi-centre Phase III Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients Under the Age of 6 Years
Date of first enrolment:	August 2005
Target sample size:
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT02263469
Study type:	Interventional
Study design:	N/A
Phase:	Phase 3

Countries of recruitment
Poland	Ukraine

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients under six years of age at the time of entry with severe Haemophilia B at the
time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.

Exclusion Criteria:

-

Age minimum: N/A
Age maximum: 6 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Haemophilia B

Intervention(s)

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

Primary Outcome(s)

Amount of Factor IX Administered per Month (IU/KG) [Time Frame: 26 Weeks]

Secondary Outcome(s)

Secondary ID(s)

R9VF03

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:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.