5 completed, 4 terminated. 4 Phase 1, 3 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 3, Terminated 1 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 1 | Terminated 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 |
|---|---|---|---|---|---|---|
| A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease Natural History Observation - Recurrent Bacterial Infection, Autoimmune Disorder | Terminated | Catalyst Biosciences | 3 | 2021-08-31 | 2022-04-08 | |
| Screening Study to Identify Patients With Complement Factor I Deficiencies Previous Diagnosis With a Complement-mediated Disease and/or With Clinical Manifestations Reasonably Associated With Complement Factor I Deficiency | Terminated | Catalyst Biosciences | 113 | 2021-07-21 | 2022-04-08 | |
| Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders Coagulation Factor VIIa variant - Factor VII Deficiency, Glanzmann Thrombasthenia | Phase 1 / Phase 2 | Terminated | Catalyst Biosciences | 19 | 2021-05-17 | 2021-12-21 |
| Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B MarzAA - Hemophilia A With Inhibitor, Hemophilia B With Inhibitor | Phase 3 | Terminated | Catalyst Biosciences | 18 | 2021-05-04 | 2021-12-17 |
| Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia MarzAA (marzeptacog alfa [activated]) - Hemophilia A, Hemophilia B | Phase 1 | Completed | Catalyst Biosciences | 11 | 2019-09-24 | 2021-09-13 |
| Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B Coagulation Factor IX variant - Hemophilia B | Phase 2 | Completed | Catalyst Biosciences | 6 | 2019-06-18 | 2021-08-09 |
| Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B Coagulation Factor VIIa variant - Hemophilia A With Inhibitor, Hemophilia B With Inhibitor | Phase 2 | Completed | Catalyst Biosciences | 11 | 2017-12-18 | 2021-09-23 |
| Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg, BeneFIX - Hemophilia B | Phase 1 | Completed | ISU Abxis Co., Ltd. | 11 | 2017-06-03 | 2020-11-10 |
| Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia PF-05280602 - Hemophilia A | Phase 1 | Completed | Catalyst Biosciences | 29 | 2011-12-01 | 2017-05-12 |
Hemophilia B (3) · Hemophilia A (2) · Autoimmune Diseases (1) · Bacterial Infections (1) · Factor VII Deficiency (1) · Thrombasthenia (1)
Factor IX (1) · marzeptacog alfa (activated) (1)
United States (5) · Russia (4) · South Africa (4) · Italy (3) · Armenia (2) · Georgia (2) · Hungary (2) · India (2) · Poland (2) · Turkey (Türkiye) (2) · Ukraine (2) · United Kingdom (2) · Belgium (1) · Bulgaria (1) · Malaysia (1)
Howard Levy, MD, PhD, MMM (3) · ChurWoo You, PhD (1)