Status:
TERMINATED
A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
PNH
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate the long-term safety of daily oral treatment with BCX9930 in participants who had participated in a previous BCX9930 trial for PNH and showed a benefit of treatment...
Eligibility Criteria
Inclusion
- Male or non-pregnant, non-lactating female participants
- Successfully participated in a previous BCX9930 study of PNH and experienced improvement in their PNH
Exclusion
- Apart from a diagnosis of PNH, any clinically significant medical or psychiatric condition or medical history, other than those associated with PNH disease, that, in the opinion of the Investigator or Sponsor, would interfere with the participant's ability to participate in the study or participation would increase the risk for that participant
- Pregnant, planning to become pregnant, or having been pregnant within 90 days of Day 1, or lactating
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04702568
Start Date
December 18 2020
End Date
October 4 2023
Last Update
April 13 2025
Active Locations (5)
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1
Study Center
Vienna, Austria
2
Study Center
Bloemfontein, South Africa
3
Study Center
Cape Town, South Africa
4
Study Center
Pretoria, South Africa