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

A non-interventional study on the tolerability of Octagam® 5% and Octagam® 10%

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN02245668
Enrollment
1000
Registered
2011-10-25
Start date
2011-09-01
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Any indication, age, or treatment regimen in which Octagam is prescribed Haematological Disorders

Interventions

The individual observation period for one patient is not limited, PID patients should be observed for a minimum of 10 months, if possible.

Sponsors

Octapharma AG (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients treated with Octagam at a participitating site.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Incidence of adverse drug reactions (ADRs)

Secondary

MeasureTime frame
Efficacy of treatment

Countries

Austria, Brazil, France, Russian Federation, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026