The tolerability of Octagam® 5% and Octagam® 10%

Not Applicable

Completed

• Conditions: Any indication, age, or treatment regimen in which Octagam is prescribed; Haematological Disorders

• Registration Number: ISRCTN02245668
• Lead Sponsor: Octapharma AG (Switzerland)

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: 2011-10-25
• Study Completion: 2014-06-01
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

All patients treated with Octagam at a participitating site.

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions (ADRs)

Secondary Outcome Measures

Name	Time	Method
Efficacy of treatment