CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 116 enrolled
Drug / intervention
Octagam 10%drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00426270
NCT00426270Phase 3Completed
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Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults

Octapharma·interventional·Posted Jan 24, 2007·Updated Aug 1, 2014

In Brief

A Phase 3 clinical trial evaluating Octagam 10% for Immune Thrombocytopenic Purpura. Completed, enrolled 116 participants across 1 site.

Detailed Summary

Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenic Purpura
CountriesAustria
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2007
Enrollment StartJun 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.4 years ago

Interventions

Octagam 10%drug

Octagam 10% was supplied as a ready-to-use solution in glass bottles.