Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

• Conditions: Hemophilia B; MedDRA version: 17.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-004155-32-Outside-EU/EEA
• Lead Sponsor: Wyeth Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-06
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

1.Severe hemophilia B (plasma FIX activity level [FIX:C] less than or equal to [=<]1 percent [%]).
2.Less than 5 years of age (in order to complete study treatment before age 6).
3.In the investigator’s judgment, the subject and/or caregiver will be compliant to study procedures.
4.The parent or legal guardian has voluntarily signed and dated written informed consent before any screening procedures.

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.The subject has a currently detectable FIX inhibitor (or history of an inhibitor) defined as greater than or equal to [>=] 0.6 Bethesda Units (BU). A family history of inhibitors will not exclude the subjects.
2.Impaired hepatic function defined as greater than (>) 2.5 * Upper limit of normal (ULN) of Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and/or total bilirubin, except
in documented hyperbilirubinemia of the newborn.
3.Impaired renal function (serum creatinine >1.25 *ULN).
4.Albumin less than (<) Lower limit of normal (LLN).
5.Platelet count <100,000 per millimetre cube (mm^3).
6.Abnormal prothrombin time (>1.25 * ULN).
7.Known hypersensitivity to protein products or agents related to the test article, eg, hamster proteins.
8.Documented HIV infection; or active infection with hepatitis.
9.Any genetic coagulation disorder other than hemophilia B (with the exception of vitamin K-dependent coagulation deficiency of the newborn).
10.Received any investigational drug within 30 days before entering the study.
11.Any condition (medical or social) that, in the investigator's judgment, makes participation in the study not advisable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified