Clinical study to evaluate the efficacy and safety of Octagam 10% in Primary Immune Thrombocytopenia (ITP)

Completed

Conditions: Primary Immune Thrombocytopenia (ITP).
Haematological Disorders
Other primary thrombocytopenia

Registration Number: ISRCTN78894548

Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Age of >=18 years and <=65 years
2. Confirmed diagnosis of chronic primary ITP (threshold PC less than 100x10^9/L) of at least 12 months duration
3. Platelet count of <30x10^9/L with or without bleeding manifestations

Exclusion Criteria

1. Thrombocytopenia secondary to other diseases (such as AIDS or SLE) or drug-related thrombocytopenia
2. Administration of IVIG, anti-D or thrombopoietin receptor agonists or other platelet enhancing drugs (including immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrolment
3. Unresponsive to previous treatment with IVIG or anti-D immunoglobulin
4. Severe liver or kidney disease (ALAT 3x > upper limit of normal, creatinine >120 µmol/L)
5. Patients with risk factors for TEEs in whom the risks outweigh the potential benefit of Octagam treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Platelet count and the increase in platelets to ? and the maintenance of ? specific thresholds<br>2. Number and percentage of patients with response (R), complete response (CR), no response (NR) and loss of response as well as time to response and duration of response will be presented descriptively to facilitate the comparison of the study results to data from the literature

Secondary Outcome Measures