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NCT03489291 · ClinicalTrials.gov registry record · Phase 2
Dose Confirmation Trial of AAV5-hFIXco-Padua
A Phase 2 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03489291 is a Phase 2 study that has completed, run by CSL Behring. The registered enrollment target is 3 participants.
The verdict
NCT03489291, a Phase 2 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase. The IMP AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The IMP is identified as AAV5-hFIXco-Padua (AMT- 061). The pharmaceutical form of AMT-061 is a solution for intravenous infusion. The administered dose of AMT-061 will be 2 x 10\^13 gc/kg.
Interventions
- GENETIC AAV5-hFIXco-Padua (AMT-061)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2023-09-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03489291
The ClinicalTrials.gov registry entry for NCT03489291 describes a study currently listed as completed, categorized as Phase 2. 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 CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AAV5-hFIXco-Padua (AMT-061) is the first listed.
NCT03489291 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03489291 about?
NCT03489291 is a clinical study titled "Dose Confirmation Trial of AAV5-hFIXco-Padua". This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase. The IMP AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized ...
What is the current status of trial NCT03489291?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2018-07-24. Estimated completion is 2023-09-21.
What interventions are being tested in trial NCT03489291?
The interventions under investigation include: AAV5-hFIXco-Padua (AMT-061) (GENETIC).
Who is sponsoring clinical trial NCT03489291?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
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