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Damoctocog-alfa-pegol · 2 trials · 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. |
| 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 (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. |
| 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 (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 and prophylaxis of bleeding in people with hemophilia A, a genetic bleeding disorder caused by a lack of clotting factor VIII. It is studied in previously treated children aged 7 to less than 12 years with severe hemophilia A, as well as in adults.
Damoctocog alfa pegol is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical studies evaluating the therapy in patients with severe hemophilia A.
Damoctocog alfa pegol is investigational and remains in clinical development. Its trials span Phase 1 and Phase 3, with the Phase 3 pediatric study in severe hemophilia A now completed. It has not been established as approved based on the available development information.
Two completed trials are registered for Damoctocog alfa pegol. NCT05147662 was a Phase 3 study in previously treated children aged 7 to less than 12 years with severe hemophilia A, enrolling 36 participants across the United States, Argentina, Brazil, Canada, Italy, Norway, and Turkey. NCT04015492 was a Phase 1 study in Bulgaria comparing distribution and excretion with Adynovi in 18 adults.
Yes. Damoctocog alfa pegol is also known as Jivi and by the code name BAY94-9027. These names refer to the same Bayer hemophilia A therapy, so searches for Jivi or BAY94-9027 lead to the same product information.
Damoctocog alfa pegol is a pegylated recombinant factor VIII therapy. It is designed to replace or supplement clotting factor VIII, the protein that is missing or deficient in people with hemophilia A, thereby supporting blood clotting and helping to control or prevent bleeding episodes.