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A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia B

Intervention: rIX-FP (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Program Director, Study Director, Affiliation: CSL Behring

Summary

This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.

Clinical Details

Official title: A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incremental recovery of rIX-FP

Half-life (t1/2) of a single dose of rIX-FP

Area under the curve (AUC)

Clearance of a single dose of rIX-FP

Number of subjects developing Factor IX (FIX) inhibitors

Secondary outcome:

The frequency of related adverse events

Number of subjects developing antibodies against rIX-FP

Proportion of bleeding episodes requiring one, two or more than two infusions of rIX-FP to achieve hemostasis

Consumption of rIX-FP

Eligibility

Minimum age: N/A. Maximum age: 11 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male subjects, younger than 12 years old.

- Severe hemophilia B (Factor IX [FIX] activity of ≤ 2%).

- Body weight ≥ 10 kg.

- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >

150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years).

- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no

family history of inhibitors against FIX.

- Written informed consent for study participation.

Exclusion Criteria:

- Known hypersensitivity to any FIX product or hamster protein.

- Known congenital or acquired coagulation disorder other than congenital FIX

deficiency.

- Kidney or liver disease.

- Recent life-threatening bleeding episode.

Locations and Contacts

The Children's Hospital at Westmead, Westmead 2145, Australia

AKH Wien (Paediatrics), Wien, Austria

Fakultni nemocnice Brno, Brno 625 00, Czech Republic

Fakultni nemocnice Ostrava, Ostrava-Poruba 708 52, Czech Republic

Fakultni nemocnice Motole, Praha 5 150 06, Czech Republic

C.R.T.H. Hop Bicetre (Hemophilie), Le Kremlin-Bicetre 94270, France

Hospital Edouard Herriot, Lyon 69003, France

Assistance Publique Hopitaux de Marseille (APHM) - Centre Ho, Marseille 13005, France

Heinrich-Heine-Universitaet, Duesseldorf 40225, Germany

CRC Coagulation Research Center GmbH, Duisburg/Altstadt 47051, Germany

Sheba Medical Center, Tel Hashomer 52621, Israel

AOU Careggi, Firenze 50134, Italy

IRCCS Ospedale Maggiore (Centro emofilia e Trombosi), Milano 20122, Italy

FGU "Kirov Research Institute of Haemotology and Blood Trans), Kirov 610027, Russian Federation

H.U. La Paz, Madrid 28046, Spain

McMaster University, Hamilton, Ontario L8L 2X2, Canada

The Henry Ekert Haemophilia Treatment Centre, Parkville, Victoria 3052, Australia

Additional Information

Starting date: September 2012
Last updated: December 15, 2014

Page last updated: August 20, 2015

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