CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
NewGamdrug
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/NCT01349790
NCT01349790Phase 3Completed
CompareCT.gov

Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia

Octapharma·interventional·Posted May 9, 2011·Updated Jun 7, 2017

In Brief

A Phase 3 clinical trial evaluating NewGam for Primary Thrombocytopenia. Completed, enrolled 40 participants across 1 site.

Detailed Summary

NewGam is a newly developed human normal immunoglobulin solution for intravenous administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in patients with primary immune thrombocytopenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Thrombocytopenia
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2011
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.1 years ago

Interventions

NewGamdrug

NewGam is a solution of human normal immunoglobulin 10% treated with solvent/detergent and nanofiltered for intravenous administration.