World Health Organization site
Skip Navigation Links

Main
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: 19 March 2012
Main ID:  EUCTR2005-003552-35-FR
Date of registration: 29/12/2006
Prospective Registration: Yes
Primary sponsor: Octapharma AG
Public title: Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A
Scientific title: Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A
Date of first enrolment: 10/05/2007
Target sample size: 116
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003552-35
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: yes Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Czech Republic France Germany
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
- Age of at least 18 years.
- Diagnosis of ITP according to standard criteria i.e. isolated thrombocytopenia with an otherwise normal peripheral blood smear (bone marrow examination optional), and absence of other causes of thrombocytopenia.
- Platelet count of 20.000/µL or less with or without bleeding manifestations.
- Freely given written informed consent from patient.
- Women of reproductive age: negative result on a pregnancy test (HCG-based assay) and will practice contraception using a method of proven reliabilty for the duration of the study.
women of reproductive age: negative result on apregnancy test (HCG-based assay) and will practise 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Chronic refractory ITP patients, defined as those who fail to respond to standard treatment (oral corticosteroids and intravenous immunglobulin and anti-D) or require unacceptably high doses of corticosteroids to maintain a safe platelet count.
- Thrombocytopenia secondary to other diseases (such as AIDS) or drug-related thrombocytopenia.
- Administration of IGIV, anti-D or other platelet enhancing drugs within 30 days before enrollment, except for long-term corticosteroid therapy in patients with chronic ITP when the dose has been stable during the preceding 30 days and no dosage increase is planned within 7 days after treatment.
- Experimental treatment (eg Rituximab) within 3 months before enrollment.
- Prophylactic preoperative treatment for elective splenectomy.
- Live viral vaccination within the last month before study entry.
- Emergency operation.
- Severe liver or kidney disease (ALAT 5x > normal value, creatinine > 120 µmol/L).
- History of hypersensitivity to blood or plasma derived products, or any component of the product, such as maltose.
- Known IgA deficiency and antibodies against IgA.
- History of, or suspected drug abuse.
- Pregnant and nursing women.
- Unable or unwilling to comply with the study protocol.
- Participating in another clinical study currently or during the 3 months before study entry.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
the medical condition which have to be investigated is the evolution of platelets counts in adults with a idiopathic thrombocytopenic purpura, with less than 20 10^9 platelets/L and treated by Octagam10% (immunoglobulines).
Intervention(s)

Product Name: Octagam® 10%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Immunoglobulin
Current Sponsor code: GAM10
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: To investigate the efficacity of Octagam®10% in correcting the platelet count.
Primary end point(s): premary endpoint is an increase in platelet count to = 50 x 10^9/L within 7 days after treatment.
Secondary Objective: To investigate the safety of Octagam®10%.
Secondary Outcome(s)
Secondary ID(s)
2005-003552-35-DE
GAM10-02
N/A
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history