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Ferric derisomaltose · 1 trial · 3 indications
To determine the effect of IV iron supplementation provided at least 21 days prior to surgery for gynecologic malignancy on mean preoperative haemoglobin concentration (in g/L)in patients with iron deficiency anemia compared to those patients without preoperative IV iron supplementation.
| Arm | Type | Description |
|---|---|---|
| Iron Therapy Arm | EXPERIMENTAL | 500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight \<50kg will receive 500mg, participants with bodyweight \>50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight. |
| Placebo Arm | PLACEBO_COMPARATOR | 100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention. |
| Name | Type | Description |
|---|---|---|
| Ferric derisomaltose | DRUG | Ferric Derisomaltose is a solution based iron supplement provided in 100 mg elemental iron/mL. Patients randomized to Iron Therapy Arm will with a bodyweight \<50kg will receive 500mg of Ferric Derisomaltose, and patients with a bodyweight \>50kg will receive 1000mg of Ferric Derisomaltose, to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg. Patients will receive a single infusion between 21 and 90 days preceding surgical intervention. |
| Placebo | DRUG | Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour. |
Inclusion Criteria: 1. Signed written informed consent prior to initiation of any study specific activities/procedures. 2. Age ≥ 18 years old. 3. Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion: 1. The i...
Ferric derisomaltose is an investigational small molecule being studied for the treatment of gynecologic cancer, specifically to address anemia and iron deficiency in patients undergoing surgery. It is being evaluated in a Phase 3 clinical trial for its role in recovery outcomes for gynecologic oncology patients.
Ferric derisomaltose is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy in gynecologic cancer patients with anemia and iron deficiency.
Ferric derisomaltose is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting participants to assess its safety and efficacy in the target patient population.
Ferric derisomaltose is being studied in a Phase 3 clinical trial registered as NCT05407987, titled "Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)." The trial is recruiting 82 female participants aged 18 years and older in Canada.
Ferric derisomaltose is a distinct iron replacement product. It is being studied specifically for its effects on recovery in gynecologic cancer surgery patients. The ongoing clinical trial focuses on its use in treating anemia and iron deficiency in this population.