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NCT04541628 · ClinicalTrials.gov registry record · Phase 1
Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A
A Phase 1 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT04541628 is a Phase 1 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 3 participants.
The verdict
NCT04541628, a Phase 1 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
SIG-001-121 is a first-in-human (FIH), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A without inhibitors. Up to three dose cohorts (3 patients each) are planned. Cohort expansions (up to 3 additional patients) may be triggered to collect additional information about safety and efficacy.
Interventions
- COMBINATION_PRODUCT SIG-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2023-01-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04541628
The ClinicalTrials.gov registry entry for NCT04541628 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SIG-001 is the first listed.
NCT04541628 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04541628 about?
NCT04541628 is a clinical study titled "Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A". SIG-001-121 is a first-in-human (FIH), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A without inhibitors. Up to three dose cohorts (3 patients each) are planne...
What is the current status of trial NCT04541628?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2020-09-28. Estimated completion is 2023-01-09.
What interventions are being tested in trial NCT04541628?
The interventions under investigation include: SIG-001 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04541628?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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