Tolerability and safety of octagam® 5%, octagam® 10% and panzyga®

Not Applicable

Recruiting

• Conditions: Autoimmune diseases; Haematological Disorders

• Registration Number: ISRCTN68324970
• Lead Sponsor: Octapharma GmbH (Germany)

Brief Summary

1. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27719744 .

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-19
• Last Update Posted: 10 December 2018
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Patients of any age and gender, who receive treatment with octagam® 5%, octagam® 10% or panzyga®

Exclusion Criteria

Patients with known contraindications as specified in the Summary of Product Characteristics (SPC)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The physician will have to fill out CRFs and send them back in a bunch of six subsequent documented treatments including one form which describes the progress of the treatment over this period. The individual observation period is not limited.

Secondary Outcome Measures

Name	Time	Method
Quality of life will be evaluated by using the SF-36 health survey