Clinical trial
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
NCT03569891 · CSL Behring, Industry · Completed
Key facts
| NCT number | NCT03569891 |
|---|---|
| Title | HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients |
| Official title | Phase III, Open-label, Single-dose, Multi-center, Multinational Trial Investigating a Serotype 5 Adeno-associated Viral Vector Containing the Padua Variant of a Codon-optimized Human Factor IX Gene (AAV5-hFIXco-Padua, AMT-061) Administered to Adult Subjects With Severe or Moderately Severe… |
| Lead sponsor | CSL Behring, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hemophilia B |
| Intervention type | Biological, Genetic |
| Interventions | AAV5-hFIXco-Padua, Factor IX (FIX) |
| Enrollment | 67 |
| Start date | Jun 27, 2018 |
| Primary completion | Sep 22, 2021 |
| Completion | Mar 19, 2025 |
| First posted | Jun 26, 2018 |
| Last update posted | May 4, 2025 |
| Countries | Belgium, Denmark, Germany, Ireland, Netherlands, Sweden, United Kingdom, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: