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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 22 April 2013
Main ID:  EUCTR2012-000796-16-BG
Date of registration: 22/05/2012
Prospective Registration: Yes
Primary sponsor: OCTAPHARMA AG
Public title: Study to evaluate the efficacy and safety of human immune globulin in patients with primary immune thrombocytopenia
Scientific title: PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA
Date of first enrolment: 18/07/2012
Target sample size: 30
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000796-16
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Bulgaria Czech Republic Poland
Contacts
Name: Clinical Research Department   
Address:  Oberlaaer Straße 235 1100 Vienna Austria
Telephone: +43 1 610321295
Email: clinical.department@octapharma.com
Affiliation:  Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Name: Clinical Research Department   
Address:  Oberlaaer Straße 235 1100 Vienna Austria
Telephone: +43 1 610321295
Email: clinical.department@octapharma.com
Affiliation:  Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Key inclusion & exclusion criteria
Inclusion criteria:
• Age of >=18 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

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Intervention(s)

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%
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: To assess the efficacy of Octagam 10% in correcting the platelet count (PC).
Primary end point(s): The primary efficacy measure is the PC and the increase in platelets to – and the maintenance of – specific thresholds.
Secondary Objective: To evaluate the safety of Octagam 10%.
Timepoint(s) of evaluation of this end point: continuously, see protocol
Secondary Outcome(s)
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
Secondary ID(s)
2012-000796-16-CZ
GAMr-30
Source(s) of Monetary Support
Octapharma AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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