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NCT03569891 · ClinicalTrials.gov registry record · Phase 3
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
NCT03569891 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 67 participants.
The verdict
NCT03569891, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 67 participants
- Enrollment target
Study Summary
This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). 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 pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10\^13 gc/kg.
Interventions
- BIOLOGICAL Factor IX (FIX)
- GENETIC AAV5-hFIXco-Padua
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2025-03-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03569891
The ClinicalTrials.gov registry entry for NCT03569891 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 67 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 2 interventions - of which Factor IX (FIX) is the first listed.
NCT03569891 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03569891 about?
NCT03569891 is a clinical study titled "HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients". This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containi...
What is the current status of trial NCT03569891?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2018-06-27. Estimated completion is 2025-03-19.
What interventions are being tested in trial NCT03569891?
The interventions under investigation include: Factor IX (FIX) (BIOLOGICAL), AAV5-hFIXco-Padua (GENETIC).
Who is sponsoring clinical trial NCT03569891?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
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