Clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) in Primary Immune Thrombocytopenia

Phase 3

Completed

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

• Registration Number: ISRCTN37539930
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30687970 (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-27
• Study Completion: 2013-06-30
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Age of >=18 years years and <=65 years
2. Confirmed diagnosis of chronic primary ITP of at least 12 months duration (diagnosed with threshold platelet count less than 100x109/L)
3. Platelet count of <=20x10exp9/L with or without bleeding manifestations

Exclusion Criteria

1. Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia.
2. Administration of intravenous immunoglobulin (IGIV), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment
3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
4. Severe liver or kidney disease (alanine aminotransferase [ALAT] 3x > upper limit of normal, creatinine >120 µmol/L).
5. Patients with risk factors for thromboembolic events in whom the risks outweigh the potential benefit of NewGam treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified