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NCT02263469 Clinical Trial

A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years

Haemophilia B Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02263469
Other study ID # R9VF03
Secondary ID
Status Completed
Phase Phase 3
First received September 2, 2014
Last updated October 9, 2014
Start date August 2005

Study information
Verified date August 2014
Source Bio Products Laboratory
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of HealthUkraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Years
Eligibility 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:

Study Design

N/A

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Poland Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576 Warsaw
Ukraine Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue Donetsk
Ukraine Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str. Kiev
Ukraine Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str. Lviv

Sponsors (1)
Lead Sponsor Collaborator
Bio Products Laboratory

Countries where clinical trial is conducted

Poland,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of Factor IX Administered per Month (IU/KG) 26 Weeks
See also
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Completed NCT03055611 - A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Active, not recruiting NCT05365217 - A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B Phase 3
Completed NCT01467427 - Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B. Phase 3
Completed NCT03075670 - A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B Phase 1
Completed NCT02300519 - Thrombin Generation Numerical Models Validation in Haemophilic Case N/A
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