5 completed, 2 terminated, 1 recruiting. 8 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 5, Terminated 2, Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) Trimodulin, Placebo (human albumin 1%) - Community-acquired Pneumonia | Phase 3 | Recruiting | Biotest | 590 | 2023-09-09 | 2026-09-14 |
| Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia Trimodulin, Placebo (human albumin 1%) - Respiratory Infection, Pneumonia | Phase 3 | Terminated | Biotest | 107 | 2022-12-22 | 2025-06-08 |
| Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) BT097 - Congenital Cytomegalovirus Infection | Phase 3 | Terminated | Biotest | 48 | 2021-11-17 | 2025-03-10 |
| Adjusted Fibrinogen Replacement Strategy BT524, FFP/Cryo - Bleeding Disorder, Hypofibrinogenemia; Acquired | Phase 3 | Completed | Biotest | 222 | 2018-04-03 | 2025-06-13 |
| This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP) BT595 - Immune Thrombocytopenia | Phase 3 | Completed | Biotest | 34 | 2016-11-01 | 2019-08-14 |
| Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID IgG Next Generation (BT595) - Primary Immunodeficiency Disease | Phase 3 | Completed | Biotest | 81 | 2016-10-04 | 2023-07-20 |
| Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency BT524 (Part I), BT524 (Part II) - Congenital Afibrinogenemia, Congenital Hypofibrinogenemia | Phase 3 | Completed | Biotest | 67 | 2013-03-01 | 2025-07-03 |
| A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant Zutectra - Hepatitis B | Phase 3 | Completed | Biotest | 49 | 2012-12-01 | 2015-03-25 |
Afibrinogenemia (2) · Community-Acquired Pneumonia (2) · COVID-19 (1) · Cytomegalovirus Infections (1) · Hemorrhage (1) · Hemostatic Disorders (1) · Hepatitis B (1) · Pneumonia (1) · Pneumonia, Bacterial (1) · Pneumonia, Viral (1) · Primary Immunodeficiency Diseases (1) · Purpura, Thrombocytopenic, Idiopathic (1) · Respiratory Distress Syndrome (1) · Respiratory Tract Infections (1)
trimodulin (2) · BT088 immunoglobulin, human (1) · Fluid Therapy (1) · Immunoglobulins, Intravenous (1) · Solutions (1) · cryoprecipitate coagulum (1) · gamma-Globulins (1) · hepatitis B hyperimmune globulin (1)
Germany (7) · Spain (6) · Hungary (4) · Belgium (3) · Czechia (3) · France (3) · United Kingdom (3) · Argentina (2) · Austria (2) · Brazil (2) · Bulgaria (2) · South Africa (2) · United States (2) · Australia (1) · Egypt (1)
Antoni Torres, Prof (1) · Claudia Djambas Khayat, MD (1) · Didier Samuel, Professeur (1) · Gergely Krivan, MD (1) · Judit Demeter, MD, PhD, DSc (1) · Karl O Kagan, Prof (1) · Niels Rahe-Meyer, Prof. (1) · Ricard Ferrer Roca, Dr. (1)
PMID 35944615, PMID 36383294, PMID 36448274, PMID 40741224, PMID 41702298, PMID 42247815
2015 (1), 2017 (1)