Trial12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
Trial details
- Registry ID
- NCT02303626
- Phase
- Phase 2, Phase 3
BCRX
BioCryst Pharmaceuticals
Company identity has not yet been verified
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11Trials in this database
4Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
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Included trials
Check company identity sourceA Long Term Safety Study of BCX7353 in Hereditary Angioedema
Trial details
- Registry ID
- NCT03472040
- Phase
- Phase 2, Phase 3
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
Trial details
- Registry ID
- NCT03485911
- Phase
- Phase 3
Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan
Trial details
- Registry ID
- NCT03873116
- Phase
- Phase 3
A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Trial details
- Registry ID
- NCT04702568
- Phase
- Phase 2
Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
Trial details
- Registry ID
- NCT04933721
- Phase
- Phase 3
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy
Trial details
- Registry ID
- NCT05116774
- Phase
- Phase 2
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants Not Receiving Other Complement Inhibitor Therapy
Trial details
- Registry ID
- NCT05116787
- Phase
- Phase 2
Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)
Trial details
- Registry ID
- NCT05162066
- Phase
- Phase 2
Berotralstat Treatment in Children With Hereditary Angioedema
Trial details
- Registry ID
- NCT05453968
- Phase
- Phase 3
Long-term Safety of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria
Trial details
- Registry ID
- NCT05741346
- Phase
- Phase 2
Latest recorded trial changes
Berotralstat Treatment in Children With Hereditary Angioedema
NCT05453968 · BioCryst Pharmaceuticals
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
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− Before
Measure: Pharmacokinetics: Cmax
Measure: Pharmacokinetics: AUC0-tau
Measure: Pharmacokinetics: CL/F
+ After
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of Berotralstat Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6) of Berotralstat Measure: Concentration at the End of the Dosing Interval (Ctrough) of Berotralstat Measure: Maximum Observed Plasma Concentration (Cmax) of Berotralstat Measure: Time of Last Measurable Plasma Concentration (Tlast) of Berotralstat Measure: Time to Maximum Plasma Concentration (Tmax) of Berotralstat
Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
NCT04933721 · BioCryst Pharmaceuticals
Recruitment status changed
− Before
Active not recruiting
+ After
Enrolling by invitation
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
NCT02303626 · BioCryst Pharmaceuticals
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: The mean acute angioedema attack rate
+ After
Measure: The Mean Acute Angioedema Attack Rate
Long-term Safety of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria
NCT05741346 · BioCryst Pharmaceuticals
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Proportion of Participants with Treatment Emergent Adverse Events (TEAEs)
+ After
Measure: Number of Participants With Treatment-emergent Events (TEAEs)