Tolerability of the intravenous immunoglobulin Octagam® 10%

Not Applicable

Completed

• Conditions: Primary or secondary immunodeficiencies, immunomodulation in autoimmune diseases; Haematological Disorders; Other immunodeficiencies

• Registration Number: ISRCTN58800347
• Lead Sponsor: Octapharma GmbH (Germany)

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29020871 post-authorisation safety analysis 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29517417/ (added 14/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-03
• Study Completion: 2013-09-14
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Patients of any age and gender who receive treatment with Octagam® 10%

Exclusion Criteria

Patients with known contraindications to Octagam® 10%

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the tolerability of Octagam® 10% in different indication groups in routine clinical practice

Secondary Outcome Measures

Name	Time	Method
Data about the efficacy of Octagam® 10%