Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-003552-35-DE
• Date of registration: 13/01/2006
• Prospective Registration: Yes
• Primary sponsor: Octapharma AG
• Public title: Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A
• Scientific title: Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A
• Date of first enrolment: 28/03/2006
• Target sample size: 116
• Recruitment status: Not Recruiting
• 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: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Czech Republic, France, Germany

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.
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

Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0 Level: LLT Classification code 10021245

Intervention(s)

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

Primary Outcome(s)

Main Objective: The main objective of the study is to investigate the efficacy of Octagam® 10% in correcting the platelet count.

Secondary Objective: The secondary objective of the study is to investigate the safety of Octagam® 10%.

Primary end point(s): The primary endpoint is an increase in platelet count to at least 50.000/µL within 7 days after treatment.

Secondary ID(s)

N/A

GAM10-02