Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia
NewGam (current working title for a new IGIV formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate the safety and efficacy NewGam 10% in patients with Primary Immune Thrombocytopenia.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Platelet Count [ Time Frame: Within 7 days of first infusion and at day 22 ] [ Designated as safety issue: Yes ]
- Assessment of bleeding [ Time Frame: At baseline, then daily on Day 2 through Day 8, and on Day 15 and Day 22 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Study Completion Date:||February 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Dosage Specificatiions
NewGam 10% 1.0 g/kg over a 2-day period for a total of 2.0 g/kg.
Drug: NewGam 10%
NewGam 10% is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV
This is a Phase 3 study. The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count. The secondary objective of the study is to evaluate the safety of NewGam. Safety will be assessed by monitoring vital signs, physical examination, evaluation of adverse events (AE) recordings and laboratory parameters, and by viral safety testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349790
|Principal Investigator:||Abdulgabar Salama, MD||Universitätsklinikum Charite, Med. Fakultät der Humboldt-Universität Berlin|
|Study Director:||Wolfgang Frenzel, MD||Octapharma|