Status:
UNKNOWN
Azithromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Tel Aviv University
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
18-120 years
Phase:
PHASE4
Brief Summary
Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world with a lifetime risk of 6%. Etiology is complex, while genetic background significantly affects the risk. A...
Eligibility Criteria
Inclusion
- Males and females ≥ 18Y who carry a hereditary APC nonsense mutation as identified by APC sequencing. The sequencing is performed by the Israeli Health Ministry's certified genetic lab and the mutation is approved by a certified geneticist or genetic counsel as a nonsense stop codon mutation.
- Presence of at least 3 polyps, among which at least 1 is equal or larger than 3 mm. Polyp location is in the intact colon, in the rectal remnant in patients that underwent subtotal colectomy with ileorectal anastomosis or in the ileoanal pouch in patients who underwent total proctocolectomy with ileoanal pouch anastomosis.
- Reading and signing the informed consent form.
Exclusion
- Age \< 18Y
- Pregnancy or planning pregnancy in the near future
- Hypersensitivity to the active substance, erythromycin, any macrolide, ketolide antibiotic, soya lecithin and/or any of the following Microcrystalline cellulose, Pregelatinised maize starch, Sodium starch glycolate Type A, Colloidal anhydrous silica, Sodium laurilsulfate, Magnesium stearate, Polyvinyl alcohol, Titanium dioxide (E 171), Talc, Soya Lecithin, Xanthan Gum.
- Chromic Hypokalemia or hypomagnesemia
- Significant personal or family history of ventricular arrhythmia
- Long QT interval per ECG, or consumption of drugs that may cause prolonged QT.
- Molecular evidence of variant for the congenital long QT syndrome
- Advanced polyp or desmoids tumor that requires immediate treatment.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04454151
Start Date
August 1 2020
End Date
April 1 2022
Last Update
July 1 2020
Active Locations (1)
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1
Sourasky medical center (Ichilov)
Tel Aviv, Israel