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Damoctocog-alfa-pegol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| BAY94-9027 / Adynovi | EXPERIMENTAL | Treatment sequence A-B with washout before each treatment |
| Adynovi / BAY94-9027 | EXPERIMENTAL | Treatment sequence B-A with washout before each treatment |
| Name | Type | Description |
|---|---|---|
| Damoctocog-alfa-pegol (BAY94-9027, Jivi) | BIOLOGICAL | Single dose, 50 IU/kg BAY94-9027 (IU: international Units) |
| Rurioctocog alfa pegol (Adynovi) | BIOLOGICAL | Single dose, 50 IU/kg Adynovi |
Inclusion Criteria: * Participants with severe hemophilia A (baseline FVIII activity FVIII:C \<1%), determined by measurement at the time of screening (following a washout period of at least 72 h after their last FVIII treatment for standard half-life FVIII products or of 120 h for extended half-li...
Damoctocog alfa pegol is used for the treatment of bleeding and for prophylaxis of bleeding in patients with hemophilia A, a genetic bleeding disorder caused by a lack of clotting factor VIII. It is being studied in children aged 7 to less than 12 years with severe hemophilia A.
Damoctocog alfa pegol is developed by Bayer AG, which trades under the ticker BAYRY. The drug is also known by the code name BAY 94-9027 and is marketed under the brand name Jivi in some contexts.
Damoctocog alfa pegol is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under clinical investigation for hemophilia A.
Damoctocog alfa pegol is a monoclonal antibody that targets and replaces clotting factor VIII, the protein that is deficient in hemophilia A. By providing this factor, the drug helps control and prevent bleeding episodes in patients with severe hemophilia A.
Damoctocog alfa pegol has been studied in two completed trials. NCT04015492 compared how the body distributes and excretes Jivi (BAY 94-9027) versus Adynovi in patients with severe hemophilia A. NCT05147662 evaluated the safety and effects of BAY94-9027 in previously treated children aged 7 to less than 12 years with severe hemophilia A.
Yes, Damoctocog alfa pegol is the same as Jivi, which is also known by the code name BAY 94-9027. The drug is referred to by these different names in clinical trials and commercial contexts, but they all refer to the same investigational therapy for hemophilia A.