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Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia

NCT01349790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-06-07

Study results available
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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.

Conditions

  • Primary Thrombocytopenia

Interventions

DRUG

NewGam

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

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Abdulgabar Salama, MD · Universitätsklinikum Charite, Med. Fakultät der Humboldt-Universität Berlin

  • Wolfgang Frenzel, MD · Octapharma AG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349790 on ClinicalTrials.gov