Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia
- Conditions
- Primary Immune Thrombocytopenia (ITP)MedDRA version: 14.1Level: LLTClassification code 10023095Term: ITPSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2012-000796-16-DE
- Lead Sponsor
- OCTAPHARMA AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
•Age of >=18 years and <=65 years
•Confirmed diagnosis of chronic primary ITP of at least 12 months duration and fulfilling the following criteria...
•Platelet count of <30x10^9/L with or without bleeding manifestations.
•Freely given written informed consent from patient.
•Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•Thrombocytopenia secondary to other diseases or drug-related thrombocytopenia.
•Administration of intravenous immunoglobulin (IVIG), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrolment, except for:
a) long-term corticosteroid therapy
b) long-term azathioprine, cyclophosphamide or attenuated androgen therapy
•Unresponsive to previous treatment with IVIG or anti-D immunoglobulin.
•Experimental treatment (e.g. Rituximab) within 3 months before enrolment.
•Splenectomy in the previous 4 weeks or planned splenectomy throughout the study period.
•Patient with Evans syndrome
•Known or suspected human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
•Live viral vaccination within the last 2 months before study entry.
•Emergency operation.
•Severe liver or kidney disease
•Congestive heart failure New York Heart Association (NYHA) class III or IV.
•Non-controlled arterial hypertension
•History of hypersensitivity to blood or plasma derived products, or any component of the investigational product.
•Known immunoglobulin A (IgA) deficiency and antibodies against IgA.
•History of, or suspected alcohol or drug abuse.
•Pregnant or nursing women.
•Unable to consent, or not capable to understand the nature, significance and implications of the clinical study, or unable or unwilling to comply with the study procedures.
•Vulnerable patients (e.g. kept in detention or institutionalised).
•Participating in another interventional clinical study or planned participation in another trial for the duration of this study.
•Receiving any investigational medicinal product (IMP) within 3 months before study entry.
•Patients with risk factors for thromboembolic events in whom the risks outweigh the potential benefit of Octagam treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of Octagam 10% in correcting the platelet count (PC).;Secondary Objective: To evaluate the safety of Octagam 10%.;Primary end point(s): The primary efficacy measure is the PC and the increase in platelets to – and the maintenance of – specific thresholds. ;Timepoint(s) of evaluation of this end point: continuously, see protocol
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Efficacy Endpoints:<br>•All platelet measurements will be listed and presented in standard summary statistics for each category of response and in total.<br>•Number and proportion of responders with platelets reaching normal levels <br>•Maximum PC.<br>•Regression of haemorrhages.<br>•Relationship of any new haemorrhages to PC.<br>Secondary Safety Endpoints:<br>•Vital signs.<br>•Physical examinations.<br>•AEs.<br>•Laboratory parameters<br>;Timepoint(s) of evaluation of this end point: continuously, see protocol