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SP-420 for Iron Overload
Study Summary
This trial is testing a new drug to treat patients with myelodysplastic syndrome or myelofibrosis who have too much iron in their blood. The new drug, SP-420, may be better tolerated and safer than other available drugs.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Group A
- Group 2: Group B
- Group 3: Group C
- Group 4: Group D
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the FDA sanctioned SP-420 for therapeutic use?
"Our team at Power has assigned SP-420 a score of 1 on the safety scale, as this is an early Phase I trial with limited evidence backing its efficacy and security."
Is this particular endeavor a pioneering experiment?
"Presently, there is one live trial for SP-420 across 1 city and nation. This research was initiated in 2021 by Abfero Pharmaceuticals, Inc with the goal of completing Phase 1 drug approval; 28 patients were involved to this end. Since its inception, no further trials have been executed."
Are there any vacancies left in the trial for individuals?
"Affirmative. According to clinicaltrials.gov, the trial is currently recruiting; it was first listed on March 9th 2021 and its details were most recently modified on August 25th 2022. 28 patients must be enrolled from a single medical centre."
How many participants are being sought for this medical study?
"Affirmative. Per the information on clinicaltrials.gov, this experiment is actively enrolling participants. The initial post was made March 9th 2021 with a recent update of August 25th 2022. They are searching for 28 volunteers across 1 site."
Has any prior experimentation been conducted with SP-420?
"Presently, there is one trial being conducted for SP-420 with none of them currently in the final stage. These trials are concentrated in San Antonio, Texas however there is only a single site carrying out this clinical study."
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