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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: Completed Phase 1 study of Dehydrated Hereditary Stomatocytosis, sponsored by Boston Children's Hospital.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Reticulocyte count, bilirubin, LDH, Hemoglobin
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 |
What the finished NCT04372498 record still lists
NCT04372498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04372498's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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