CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Immunoglobulin Intravenous (Human)biological
Likely dose
1 g IgG per kg body weight on two consecutive days (total 2 g IgG/kg per treatment cycle)AI-extracted
Key inclusion· 2
  • ✓Diagnosis of chronic ITP with platelet count ≤150×10^9/L for ≥6 months OR response to prior treatment with subsequent platelet count decrease
  • ✓Current platelet count ≤20×10^9/L at study entry
Key exclusion· 9
  • ✕Planned splenectomy during study period
  • ✕IVIG or anti-D immunoglobulin within 3 weeks prior to screening
  • ✕Immunosuppressive or immunomodulatory drugs within 3 weeks prior to screening
  • ✕Intravenous steroids within 10 days prior to screening

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

Search/NCT00168038
NCT00168038Phase 3Completed
CompareCT.gov

An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

CSL Behring·interventional·Posted Sep 14, 2005·Updated Nov 23, 2011

In Brief

A Phase 3 clinical trial evaluating Immunoglobulin Intravenous (Human) for Immune Thrombocytopenic Purpura. Completed, enrolled 58 participants across 17 sites in 6 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10\^9/L.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenic Purpura
CountriesGermany, Italy, Poland, Russia, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartDec 1, 2004
Study CompletionFeb 1, 2006
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

Immunoglobulin Intravenous (Human)biological

A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.