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Iron Chelator
SP-420 for Iron Overload
Phase 1
Waitlist Available
Led By Elizabeth Bowhay-Carnes, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Summary
This trial tests SP-420, a new medicine that helps remove excess iron from the body, in patients with MDS and MFS who have too much iron due to regular blood transfusions. SP-420 may be easier to use and safer than current treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Completion at original dose
Number of adverse events
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group DExperimental Treatment1 Intervention
Study subjects will receive a 56mg/kg starting dose of SP-420 three times a week
Group II: Group CExperimental Treatment1 Intervention
Study subjects will receive a 42mg/kg starting dose of SP-420 three times a week
Group III: Group BExperimental Treatment1 Intervention
Study subjects will receive a 28mg/kg starting dose of SP-420 three times a week
Group IV: Group AExperimental Treatment1 Intervention
Study subjects will receive a 14mg/kg starting dose of SP-420 three times a week
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Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
457 Previous Clinical Trials
91,573 Total Patients Enrolled
Abfero Pharmaceuticals, IncIndustry Sponsor
1 Previous Clinical Trials
1 Trials studying Iron Overload
Elizabeth Bowhay-Carnes, MDPrincipal InvestigatorUT Health San Antonio
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently getting strong drugs or radiation for another cancer.You have sickle cell disease and too much iron in your blood from transfusions.You have severe liver problems classified as Child-Pugh class C.You have been diagnosed with a specific type of blood disorder and have too much iron from receiving multiple blood transfusions.You have high levels of protein in your urine, as shown on a urine dipstick test.You have heart failure with noticeable symptoms.If you have MDS, your condition must be assessed as intermediate, high, or very high risk based on a specific scoring system.Patients with MF must have a certain level of risk based on a specific scoring system called Dynamic International Prognostic Scoring System-Plus (DIPSS-Plus).Your ALT liver enzyme level is not more than 3 times the normal range.Your blood ferritin level is 1000 ng/ml or higher.Your kidney function, measured by a test called the Cockroft-Gault equation, is at least 60 mL/min/1.73m2.You have received 10 or more units of packed red blood cells in the last 24 months and still need regular red blood cell transfusions.You are able to perform daily activities without help.You have a history of kidney disease, including a condition called renal Fanconi syndrome.You have an active hepatitis B or C infection, shown by a positive viral PCR test.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
- Group 3: Group C
- Group 4: Group D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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