Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A

Phase 1

• Conditions: 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).

• Registration Number: EUCTR2005-003552-35-FR
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-29
• Study Completion: 2008-09-15
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified