NCT02231944

Brief Summary

To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study. To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

7 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

6.3 years

First QC Date

September 2, 2014

Last Update Submit

February 20, 2018

Conditions

Haemophilia B

Outcome Measures

Primary Outcomes (1)

  • Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.

    Safety assessments included: * assessment of tolerance at injection site * assessment of Factor IX inhibitor development * assessment of frequency and type of adverse event * routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable) * screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).

    Baseline and 3 months post-baseline.

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

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previously treated patients
  • At least 12 years of age
  • Severe Haemophilia B and without inhibitor to factor IX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Klinika Hematologii Instytutu Medycyny Wewnetrznej

Lodz, Poland

Location

Klinika Hematologii AM Lublin, ul.Jaczewskiego 8

Lublin, Poland

Location

Addenbrooke's Hospital, Hills Road

Cambridge, United Kingdom

Location

University Hospital of Wales, Heath Park

Cardiff, United Kingdom

Location

The Royal London Hospital

London, United Kingdom

Location

Manchester Royal Infirmary, Oxford Road

Manchester, United Kingdom

Location

Norwich and Norfolk Hospital

Norwich, United Kingdom

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
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 4, 2014

Study Start

July 1, 1997

Primary Completion

October 1, 2003

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

GB(5)PL(2)