Research and development

Clinical trials

Clinical trials are the central step in drug development. Here you will find a list of all of Biotest’s current clinical trials.

Clinical immunology

The following clinical trials have been conducted and completed:

IgG Next Generation (Study 991) / Yimmugo: Primary Immune Deficiency (PID)

An open label, prospective, multicenter phase III study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003652-52/DE

IgG Next Generation (Study 992) / Yimmugo: Idiopathic Thrombocytopenic Purpura (ITP)

An open label, prospective, randomized, multicenter phase III study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003653-17/ES

Intensive care medicine

Title

Indication

Status

 
Trimodulin (Study 982; CIGMA) Severe community acquired pneumonia Trial completed

A prospective randomized, double-blind, placebo-controlled, multicenter, parallel-group, adaptive group-sequential Phase II Study, to determine the efficacy and safety of BT086 as an adjunctive treatment in severe community acquired pneumonia (sCAP)

Link clinicaltrials.gov
 
Trimodulin (Study 996; ESsCAPE) Severe community acquired pneumonia Trial ongoing

A randomized, placebocontrolled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP)