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

Non-interventional safety study on the tolerability and safety of octagam® 5%, octagam® 10% and panzyga®

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN68324970

Enrollment

5000

Registered

2013-11-19

Start date

2014-02-01

Completion date

Unknown

Last updated

2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune diseases Haematological Disorders Autoimmune diseases

Interventions

Treatment with octagam® 5%, octagam® 10% or panzyga® will be documented. This includes data about the patient's disease, age, gender, weight, concomitant medication or illness. For each application, t

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Quality of life will be evaluated by using the SF-36 health survey	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026