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Iron Supplement
Ferric Derisomaltose for Gynecologic Cancers
Phase 3
Waitlist Available
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation
Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Awards & highlights
Study Summary
This trial will help determine if preoperative ferric derisomaltose/iron isomaltoside can reduce transfusion rates and improve outcomes in patients undergoing surgery for gynecologic malignancy.
Who is the study for?
This trial is for adults over 18 with iron-deficiency anemia who are scheduled for elective major gynecologic oncology surgery within the next 28-90 days. They must have low hemoglobin and transferrin saturation levels, not be pregnant, and agree to use contraception. Exclusions include other causes of anemia, hypersensitivity to the drug being tested, certain infections or liver diseases, recent iron therapy or erythropoietin use, pregnancy/lactation, psychiatric/social issues affecting compliance.Check my eligibility
What is being tested?
The trial tests if ferric derisomaltose can correct pre-operative iron-deficiency anemia better than a placebo in patients undergoing surgery for gynecologic malignancy. It's randomized and double-blinded; participants won't know if they're getting the actual drug or a dummy treatment.See study design
What are the potential side effects?
Potential side effects of ferric derisomaltose may include allergic reactions due to hypersensitivity to the medication or its components. The exact side effects will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I received the study treatment between 21 and 90 days before my scheduled surgery.
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I am scheduled for a major elective surgery in gynecologic oncology.
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I am not pregnant or have confirmed it with a test recently.
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I have undergone a major surgery lasting more than an hour.
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My surgery is scheduled between 28 to 90 days from now.
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I am 18 years old or older.
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I am having surgery for a suspected or confirmed gynecologic cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean preoperative haemoglobin concentration
Secondary outcome measures
Assessment of the requirement of postoperative blood transfusion
Clinical surgical complications
Clinical surgical site infection
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Iron Therapy ArmExperimental Treatment1 Intervention
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.
Group II: Placebo ArmPlacebo Group1 Intervention
100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.
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Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received the study treatment between 21 and 90 days before my scheduled surgery.My cervical cancer is at stage 2A or more advanced.I am scheduled for a major elective surgery in gynecologic oncology.I am not pregnant or have confirmed it with a test recently.Your hemoglobin level is lower than 120 g/L and your transferrin saturation is less than 20%.I have a long-term liver condition or active hepatitis.I have undergone a major surgery lasting more than an hour.My surgery is scheduled between 28 to 90 days from now.You have anemia caused by something other than the condition being studied, such as a deficiency in B12 or folate, or a blood disorder.You are allergic to Ferric derisomaltose/iron isomaltoside (Monoferric®) or any of its ingredients.I can understand and follow the study's procedures without any limitations from psychiatric, social, or substance issues.I am on immunosuppressive therapy for an organ transplant or will be on dialysis.I am 18 years old or older.I have had a fever over 38C or am currently on antibiotics not for prevention.I have not had erythropoietin or IV iron therapy in the last 12 weeks.I have a history of too much iron in my blood or it runs in my family.I am having surgery for a suspected or confirmed gynecologic cancer.Your ALT or AST levels are more than three times the normal range.I am not a candidate for planned surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Iron Therapy Arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you tell me if this experiment is still enrolling test subjects?
"The trial in question, which was created on September 1st, 2022 and edited June 3rd, 2022, is not enrolling patients at this time. However, there are 339 other trials that are currently looking for participants."
Answered by AI
Are there any risks associated with taking Ferric derisomaltose?
"Ferric derisomaltose has received a score of 3 for safety from our team at Power. This is due to the Phase 3 trial status, meaning that there is both efficacy and safety data from multiple rounds of testing."
Answered by AI
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