NCT02263469

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
Last Updated

October 13, 2014

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

September 2, 2014

Last Update Submit

October 9, 2014

Conditions

Haemophilia B

Outcome Measures

Primary Outcomes (1)

  • Amount of Factor IX Administered per Month (IU/KG)

    26 Weeks

Study Arms (1)

Replenine®-VF

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

Interventions

Replenine®-VF (High Purity Factor IX)BIOLOGICAL
Replenine®-VF

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576

Warsaw, Poland

Location

Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue

Donetsk, 83045, Ukraine

Location

Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.

Kiev, Ukraine

Location

Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.

Lviv, 79044, Ukraine

Location

Related Links

MeSH Terms

Conditions

Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

October 13, 2014

Study Start

August 1, 2005

Primary Completion

July 1, 2006

Last Updated

October 13, 2014

Record last verified: 2014-08

Locations

PL(1)UA(3)