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

Title

Indication

Status

 
CMV Hyperimmunoglobulin (CMVIG) (Study 997; PreCyssion) Prevention of prenatal CMV transmission Trial approved

Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection with gestational age ≤ 14 weeks - an open-label, single-arm, prospective trial investigating efficacy and safety of CMVIG CP Biotest.

Link clinicaltrialsregister.eu
 
IgG Next Generation (Study 991) Primary Immune Deficiency (PID) Trial completed

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)

Link clinicaltrialsregister.eu
 
IgG Next Generation (Study 992) Idiopathic Thrombocytopenic Purpura (ITP) Trial completed

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)

Link clinicaltrialsregister.eu
 

Intensive care medicine

Title

Indication

Status

 
Fibrinogen (Study 995; AdFirst) Acquired fibrinogen deficiency Trial ongoing

A randomized, active-controlled, multicenter, phase III study investigating efficacy and safety of intra-operative use of BT524 (human fibrinogen concentrate) in subjects undergoing major major spinal or abdominal surgery (AdFirst).

Link clinicaltrials.gov
 
Fibrinogen (Study 984) Congenital fibrinogen deficiency Trial completed

A prospective, open-label, phase I/III study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiency.

Link clinicaltrials.gov
 
Trimodulin (Study 998, ESsCOVID) Severe COVID-19 Trial completed

A randomized, placebo-controlled, double-blind, multi-center, phase II trial investigating the efficacy and safety of trimodulin (BT588) as add-on therapy to standard of care in adult subjects with severe COVID-19.

Link clinicaltrials.gov
 
Trimodulin (Study 970) Healthy subjects Trial completed

A prospective, randomized, placebo-controlled, and single-blind Phase I study investigating safety, tolerability, and pharmacokinetic properties of IgM Concentrate BT086 in healthy subjects

 
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
 
Hyperimmune immunoglobulin to SARS-CoV-2 (CoVIg-19)*
(Inpatient Treatment With Anti-Coronavirus Immunoglobulin (ITAC))
*under joint development by the CoVIg-19 Plasma Alliance
COVID-19 Trial ongoing

An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19.

Link ITAC-Studie