Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Octagam 10%
Product Name: Octagam 10%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 308067-58-5
Current Sponsor code: Octagam 10%
Sponsors
OCTAPHARMA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age of >=18 years and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: • All platelet measurements will be listed and presented in standard summary statistics for each category of response and in total. • Number and proportion of responders with platelets reaching normal levels • Maximum PC. • Regression of haemorrhages. • Relationship of any new haemorrhages to PC. Secondary Safety Endpoints: • Vital signs. • Physical examinations. • AEs. • Laboratory parameters ;Timepoint(s) of evaluation of this end point: continuously, see protocol | — |
Countries
Bulgaria, Czech Republic, Germany, Poland
Contacts
Public ContactClinical Research Department
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Outcome results
None listed