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Damoctocog alfa pegol · 1 trial · 4 indications
The occurrence of the defined adverse events of special interest was documented during the first 4 days that a participant was exposed to the study intervention.
| Arm | Type | Description |
|---|---|---|
| Main study (Part A) and the extension study (Part B) | EXPERIMENTAL | Part A will last for 6 months. After completing Part A participants will continue in the extension study for another 18 months. |
| Name | Type | Description |
|---|---|---|
| Damoctocog alfa pegol (Jivi, BAY94-9027) | BIOLOGICAL | Part A: 40 IU/kg (up to 60 IU/kg at the investigator's discretion), two times per week (2x/week) with the first 4 infusions under medical supervision. Thereafter, participants will continue their treatment as home treatment. Dose may be increased up to 60 IU/kg if needed at any time during the study at the investigator's discretion. Part B: Each participant may continue on prophylaxis dose regimen as prescribed in part A (40 - 60 IU/kg, 2x per week) or adjustments to prophylaxis dose / dose frequency can be made at the investigator's discretion (based on the bleeding events and individual needs): Dose frequency may be decreased to every 5 days with a prophylaxis dose of 60 IU/kg. |
Inclusion Criteria: * Participants with severe hemophilia A (participant's own FVIII activity \[FVIII:C\] \<1%) * Participants must be previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 50 exposure days (EDs) at the time of signing the informed consent * P...
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.