An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)
- Conditions
- Chronic primary immune thrombocytopenia (ITP)MedDRA version: 19.0 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia System Organ Class: 100000004851Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003653-17-HU
- Lead Sponsor
- Biotest AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
a)Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the study and are willing to participate
b)Male or female, aged 18 through 75 years, inclusive
c)Diagnosis of chronic ITP (>12 months’ duration), including diagnosis of refractory ITP, and as defined by the International Working Group (Rodeghiero et al, 2009), where ITP is described as an autoimmune disorder characterized by isolated thrombocytopenia in the absence of other causes or disorders that may be associated with thrombocytopenia
d)Treatment is indicated because of a high risk of bleeding or a need to raise the platelet count
e)Mean screening platelet count of <30×109/L from 3 qualifying platelet counts performed within approximately 7 to 14 days before the start of treatment, with no individual platelet count above 35×109/L. The subject may be rescreened if the mean screening platelet count is =30×109/L.
Are the trial subjects under 18? no
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
a)Pregnancy or unreliable contraceptive measures or lactation period (females only)
b)Known intolerance to immunoglobulins or comparable substances (e.g., vaccination reaction)
c)Known intolerance to proteins of human origin or known allergic reactions to components of the study product
d)Participation in another clinical study within 90 days before entering the study or during the study and/or previous participation in this study
e)Employee or direct relative of an employee of the contract research organization, the study site, or Biotest
f)Secondary thrombocytopenia or acquired medical conditions known to be associated with secondary thrombocytopenia, such as chronic lymphocytic leukemia; lymphoma; multiple myeloma; thyroid disease; or other forms of thrombocytopenia, such as drug induced thrombocytopenia; cirrhotic liver diseases; antiphospholipid syndrome; environmental thrombocytopenia; and bone marrow diseases
g)Severe concomitant diseases that in the judgment of the investigator will interfere with the study, such as autoimmune hemolytic anemia, acute renal failure, and noncontrolled arterial hypertension
h)Laboratory findings (e.g., abnormal laboratory values for hemoglobin, transaminase levels [alanine aminotransferase, aspartate aminotransferase], total bilirubin, creatinine, blood urea nitrogen, and immunoglobulins G, A, M) that preclude participation
i)Positive Coombs test (direct and indirect)
j)Planned invasive procedures during the time frame of the study
k)Maintenance therapy with intravenous immunoglobulins (IVIgs) or infusion of IVIgs within 3 months before start of the study
l)Unresponsive to previous IVIg treatment
m)Additional therapy with high dose corticosteroids (equivalent to >30 mg prednisone/day), thrombopoietin receptor agonists, and/or immunosuppressives and/or other therapies (e.g., infusion of platelets) within 1 month before the start of the study (Note: Subjects on stable doses of ITP active treatment must not have modified the dose in the preceding 2 weeks and must maintain their prestudy dose during the study. Corticosteroids should not be given as a premedication. Rescue therapy with short courses [i.e., 1 to 4 days] of high dose steroids and IVIgs are allowed up to 2 weeks before study inclusion.)
n)History of thrombotic events (including myocardial infarction, cerebral vascular accident [including stroke], pulmonary embolism, and deep vein thrombosis) 6 months before treatment start with BT595 or the presence of significant risk factors for thrombotic events
o)Therapy with live attenuated virus vaccines 3 months before start of the study
p)Selective, absolute immunoglobulin A (IgA) deficiency or known antibodies to IgA
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method