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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03801889
Other study ID # SP-420-705
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date August 2020
Est. completion date January 2023

Study information

Verified date September 2020
Source Abfero Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and tolerability of SP-420 and it's efficacy in terms of lowering iron in subjects with Beta-thalassemia or other rare anemias who need regular blood transfusions.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2023
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 18 years old

- Iron-overload secondary to ß-thalassemia (homozygote or compound heterozygote) or other rare anemias (e.g., aplastic anemia, pure red-cell dysplasia ) requiring chronic RBC transfusions and iron chelation therapy

- On a stable dose of iron chelation for at least 4 weeks prior to screening visit

- Weight =35 kg at screening

- Willing to discontinue current iron chelation therapy 7 days (± 3 days) prior to the first dose of SP-420 and for the duration of the current study

- LIC =5 and =25 mg/g dry weight on the R2-MRI obtained within 2 weeks prior to the baseline visit

- Cardiac T2* score > 12 msec obtained on the MRI obtained within 2 weeks prior to the baseline visit

Exclusion Criteria:

- Pregnant or breast-feeding

- Current malignancy with the exceptions of localized basal cell or squamous cell skin cancer or localized prostate cancer or is receiving immunotherapy, chemotherapy or radiation therapy for a malignancy

- Current myelodysplastic syndrome

- Alanine aminotransferase (ALT) >4 times the upper limit of normal, decompensated cirrhosis, or ascites at screening

- Past history of clinically significant kidney disease (per the Principal Investigator)

- Serum creatinine greater than the upper limit of normal during screening

- Urine protein to creatinine ratio > 0.5 mg/mg during screening

- Ongoing symptoms of cardiac dysfunction or failure

- Ongoing symptoms of neuropathy, including peripheral sensory neuropathy, peripheral motor neuropathy, or paresthesia at screening

- Received another investigational drug within 30 days or investigational antibody within 90 days of Day 1 of the study

- Other condition that, in the opinion of the PI, would interfere with the conduct of the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SP-420
Self-administered by mouth

Locations

Country Name City State
Canada University of Toronto- University Health Network Toronto
Lebanon American University of Beirut Medical Center Beirut
Thailand Siriraj Hospital Bangkok
Turkey Ege University Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Abfero Pharmaceuticals, Inc

Countries where clinical trial is conducted

Canada,  Lebanon,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of treatment-emergent Adverse Events (AEs) Week 24
Primary The incidence of treatment-emergent Adverse Events (AEs) Week 52
Secondary Change in liver iron concentration (LIC) on R2-MRI from baseline Week 24
Secondary Change in liver iron concentration (LIC) on R2-MRI from baseline Week 52
Secondary Change in cardiac iron content (CIC) on T2*-MRI from baseline Week 24
Secondary Change in cardiac iron content (CIC) on T2*-MRI from baseline Week 52
Secondary Total iron removed by chelator (in mg) from baseline Week 24
Secondary Total iron removed by chelator (in mg) from baseline Week 52
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