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Клинические исследования в Украине

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Описание
Краткое названиеIMMUNINE Pre-Treatment Study
Полное названиеIMMUNINE - Purified Factor IX Concentrate Virus-Inactivated: A Phase 4, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B Who Are Planned to Enter BAX 326 Study 250901 to Investigate a New Recombinant FIX Concentrate
СпонсорBaxter Healthcare Corporation
Industry
ИсточникBaxter Healthcare Corporation
Под контролемBulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Ukraine: State Pharmacological Center - Ministry of Health
Brazil: ANVISA Agencia Nacional de Vigilance Sanitaria
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Publica de Chile
Yes
Краткое описаниеThe primary objective of this study is to prospectively document the exposure to IMMUNINE
and to monitor FIX inhibitors over a period of approximately 20 to 50 exposure days while
receiving prophylactic treatment in a total of up to 50 previously treated patients (PTPs)
with severe (FIX level < 1%) or moderately severe (FIX level <= 2%) hemophilia B who are
planned to enter BAX326 study 250901, provided all eligibility criteria are met.

In addition, this study will evaluate the efficacy, safety, immunogenicity, thrombogenicity,
and health-related quality of life (HR QoL) of these subjects.
СостояниеИдет набор
Дата началаMay 2010
ФазаPhase 4
Вид исследованияAllocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Subject is 12 to 65 years old at the time of screening

- Subject and/or legal representative has/have provided signed informed consent

- Subject has severe (FIX level < 1%) or moderately severe (FIX level <= 2%) hemophilia
B (based on the one stage activated partial thromboplastin time (aPTT) assay), as
tested at screening at the central laboratory

- Subject is previously treated with plasma-derived or recombinant FIX concentrate(s),
cryoprecipitate or FFP for approximately 100 -150 exposure days (EDs) and is planned
to enter BAX326 study 250901.The number of EDs are derived from the subject's
treatment regimen and his/her bleeding pattern

- Subject is willing to receive prophylactic treatment for the duration of the study

- Subject is immunocompetent as evidenced by a CD4 count >= 200 cells/mm(3)

- Subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load < 200
particles/??L ~ < 400,000 copies/mL

- Female subject of childbearing potential, presents with a negative serum pregnancy
test, and agrees to employ adequate birth control measures for the duration of the
study

- Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

- The subject has a detectable factor IX inhibitor at screening, with a titer >= 0.6
Bethesda Units (BU) as determined by the Nijmegen modification of the Bethesda assay
in the central laboratory

- The subject has a history of factor IX inhibitors with a titer >= 0.6 BU (as
determined by the Nijmegen modification of the Bethesda assay or the assay employed
in the respective local laboratory) at any time prior to screening

- The subject has a history of allergic reaction, eg, anaphylaxis, following exposure
to factor IX concentrate(s)

- The subject has a known hypersensitivity to hamster proteins

- The subject has evidence of a thrombotic disease, fibrinolysis or disseminated
intravascular coagulation (DIC)

- The subject is scheduled for elective surgery, unless the surgery is medically
required within the anticipated study period

- The subject has an abnormal renal function (serum creatinine > 1.5 times the upper
limit of normal)

- The subject has severe chronic liver disease as evidenced by, but not limited to, any
of the following: International Normalized Ratio (INR) exceeding the upper limit of
normal (ULN), hypoalbuminemia, portal vein hypertension including presence of
otherwise unexplained splenomegaly and history of esophageal varices

- The subject has active hepatic disease with alanine aminotransferase (ALT) or
aspartate aminotransferase (AST) levels >= 2 times the upper limit of normal. During
the study, subjects with chronic hepatitis B or C may have fluctuations of up to 5
times the upper limit of normal but will not require discontinuation.

- The subject has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia B

- The subject's platelet count is < 100,000/mL

- The subject has a clinically significant medical, psychiatric, or cognitive illness,
or recreational drug/alcohol use that, in the opinion of the investigator, would
affect subject's safety or compliance

- The subject is currently receiving, or is scheduled to receive during the course of
the study, an immunomodulating drug other than anti-retroviral chemotherapy (eg,
?±-interferon, corticosteroid agents at a dose equivalent to hydrocortisone greater
than 10 mg/day)

- The subject is unwilling to consider further participation in study 250901 BAX326
(rFIX)

- The subject has participated in another investigational study within 30 days of
enrollment or is scheduled to participate in another clinical study involving an IP
or investigational device during the course of this study

- The subject is a member of the team conducting this study or is in a dependent
relationship with one of the study team members. Dependent relationships include
close relatives (ie, children, partner/spouse, siblings, parents) as well as
employees of the investigator or site personnel conducting the study.
ПолBoth
Минимальный возраст12 Years
Максимальный возраст65 Years
УсловиеHemophilia B
Применяемое лечение
BiologicalFactor IX Concentrate (purified, virus-inactivated)
Контакты и расположение
Lviv , 79044State Institution "Institute of Blood Pathology and Transfusion Medicine of Academy of Medical Sciences of Ukraine"
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