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

 
Cytotect 70 (Study 963) Congenital CMV infection prophylaxis Study completed

Congenital CMV infection prophylaxis

Link clinicaltrialsregister.eu
 
BT-063 (Study 977) Systemic lupus erythematosus Study completed

A prospective, open-label, mono-centre study to investigate safety, tolerability, pharmacokinetic and immunological properties of single IV doses of the humanised anti-IL-10 monoclonal antibody BT063

 

Haematology

Title

Indication

Status

 
Indatuximab Ravtansine* (Study 989) Solid tumors Study ongoing

An open-label, twostage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladder

Link clinicaltrialsregister.eu
 
Indatuximab Ravtansine (Study 969) Multiple myeloma Study completed

Safety and Dose Determining Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

 
Indatuximab Ravtansine (Study 975) Multiple myeloma Study completed

Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

 
Indatuximab Ravtansine (Study 983) Multiple myeloma Study ongoing

BT062 in Combination With Lenalidomide/Dexamethasone in Patients With Multiple Myeloma

Link clinicaltrials.gov
 

Intensive care medicine

Title

Indication

Status

 
Fibrinogen (Study 995) Acquired fibrinogen deficiency Study 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 spine surgery (AdFIrst).

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

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
 
IgM Concentrate (Study 970) Severe community acquired pneumonia Study completed

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

 
Trimodulin (Study 982) Severe community acquired pneumonia Study completed

A 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