Open Label Phase II Evaluation of Pharmacokinetics, Efficacy, and Safety of Kedrion Human Plasma-derived Antihaemophilic Double Virus inactivated and Nanofiltered Factor IX Administered to Previously Treated Severe or Moderately Severe Hemophilia B Patients - FIX PK/PD

• Conditions: Severe or Moderately Severe Hemophilia B Patients; MedDRA version: 9.1Level: LLTClassification code 10016077Term: Factor IX deficiency

• Registration Number: EUCTR2005-006186-14-IT
• Lead Sponsor: KEDRIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-13
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Age ≥ 12 years. 2. Weight > 35 kg 3. Subjects should have severe or moderately severe haemophilia B as defined by a baseline factor IX level 2%, documented at pre-enrolment screening (see Section 7.1) on the basis of anamnesis data (i.e., at haemophilia diagnosis). 4. Prior to study entry, subjects should have a history of at least 150 exposure days for all types of factor IX containing products, including fresh frozen plasma (FFP). This minimum exposure rate shall be estimated by the haemophilia treating physician. 5. If subjects are HIV-1 seropositive they should have a CD4+ lymphocyte count ≥ 400/l documented on 2 consecutive occasions over a 12 months period prior to study entry. The latest CD4+ lymphocyte count qualifying the patient for enrolment (i.e. ≥ 400/l) should be within 6 months before enrolment in the study. 6. Subjects, or their legally authorised representative in the case of study participants ≥ 12 and < 18 years of age, should have been informed of the nature of the study, agreed to its provision, and signed dated the informed consent approved by the IRB/IEC. 7. Subjects who will be available for the duration of the study will be included. At study entry all patients will be screened for the presence of HAV and HBV Antibodies; all HBV and/or HAV test negative patients will be vaccinated against Hepatitis B and/or hepatitis A before entering the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following subjects will be ineligible for enrolment: 1. Subjects with a detectable inhibitor to factor IX at the time of enrolment or a history of inhibitor to factor IX (> 0.6 BU). 2. Subjects with clinical or laboratory evidence of portal vein hypertension, such as an international normalized ratio (INR) > 1.4, the presence of splenomegaly and/or spider angiomata on physical examination and/or a history of oesophageal haemorrhage or documented oesophageal varices. 3. Subjects HIV positive who are treated with highly active anti-retroviral therapy (HAART) regimen. 4. Subjects with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives, or participation in this trial. 5. Subjects unwilling to give written informed consent to participation, or who have participated in another clinical trial within 1 month before study initiation, i.e. they have received any test drug within 30 days prior the study. The Investigator will make sure that the patients are not planning to leave the area of the study site before the end of the study period.

Study & Design

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