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NCT04372498 · ClinicalTrials.gov registry record · Phase 1
Senicapoc and Dehydrated Stomatocytosis
A Phase 1 study of Dehydrated Hereditary Stomatocytosis, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT04372498 is a Phase 1 study of Dehydrated Hereditary Stomatocytosis that has completed, run by Boston Children's Hospital. The registered enrollment target is 5 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04372498, a Phase 1 study of Dehydrated Hereditary Stomatocytosis, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Dehydrated stomatocytosis is a genetic disorder characterized by chronic hemolysis, variable anemia and erythrocyte dehydration. Causative mutations have been identified in either the Gardos (KCNN4) channel or the mechanosensitive channel PIEZO1. Senicapoc is a selective blocker of the Gardos channel that has been extensively studied in sickle cell disease and shown to be safe with limited side-effects. However, senicapoc did not meet the designated clinical endpoints in a pivotal phase 3 trial. The present study is an explanatory, proof-of-concept study of Senicapoc administered once daily in patients with familial dehydrated stomatocytosis caused by autosomal dominant V282 mutations in the Gardos (KCNN4) channel.
Conditions Studied
Interventions
- DRUG Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide)
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-04-15 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04372498
The ClinicalTrials.gov registry entry for NCT04372498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dehydrated Hereditary Stomatocytosis appearing as the primary indexed condition, and to 1 intervention - of which Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide) is the first listed.
NCT04372498 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04372498 about?
NCT04372498 is a clinical study titled "Senicapoc and Dehydrated Stomatocytosis". Dehydrated stomatocytosis is a genetic disorder characterized by chronic hemolysis, variable anemia and erythrocyte dehydration. Causative mutations have been identified in either the Gardos (KCNN4) channel or the mechanosensitive channel PIEZO1. Senicapoc is a selective blocker of the Gardos channe...
What is the current status of trial NCT04372498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2021-04-15. Estimated completion is 2024-02-01.
What conditions does trial NCT04372498 study?
This clinical trial studies the following conditions: Dehydrated Hereditary Stomatocytosis.
What interventions are being tested in trial NCT04372498?
The interventions under investigation include: Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide) (DRUG).
Who is sponsoring clinical trial NCT04372498?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04372498 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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