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NCT04676048 · ClinicalTrials.gov registry record · Phase 1
ASC618 Gene Therapy in Hemophilia A Patients
A Phase 1 study of Hemophilia A, sponsored by ASC Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04676048 is a Phase 1 study of Hemophilia A that is actively recruiting participants, run by ASC Therapeutics. The registered enrollment target is 12 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04676048, a Phase 1 study of Hemophilia A, is actively recruiting participants, sponsored by ASC Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Currently, hemophilia A patients are managed with prophylactic or on-demand replacement therapy with recombinant FVIII or alternative therapeutics. The major challenges of current treatment regimens, such as the short half-life of hemophilia therapeutics with the need for frequent IV injections, encourage the current efforts for gene transfer therapy. This study will evaluate the safety and preliminary efficacy of ASC618, an AAV vector encoding B-domain deleted codon-optimized human factor VIII under a synthetic liver-directed promoter
Conditions Studied
Interventions
- BIOLOGICAL ASC618
Study Locations (1)
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04676048
The ClinicalTrials.gov registry entry for NCT04676048 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (87% lower). The listed sponsor is ASC Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which ASC618 is the first listed.
NCT04676048 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT04676048 about?
NCT04676048 is a clinical study titled "ASC618 Gene Therapy in Hemophilia A Patients". Currently, hemophilia A patients are managed with prophylactic or on-demand replacement therapy with recombinant FVIII or alternative therapeutics. The major challenges of current treatment regimens, such as the short half-life of hemophilia therapeutics with the need for frequent IV injections, enc...
What is the current status of trial NCT04676048?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-08-03. Estimated completion is 2026-12.
What conditions does trial NCT04676048 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT04676048?
The interventions under investigation include: ASC618 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04676048?
This trial is sponsored by ASC Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04676048 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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