Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02303626 · ClinicalTrials.gov registry record · Phase 2
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
A Phase 2 study, sponsored by BioCryst Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT02303626: Completed Phase 2 study, sponsored by BioCryst Pharmaceuticals.
NCT02303626 is a Phase 2 study that has completed, run by BioCryst Pharmaceuticals. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02303626, a Phase 2 study, has completed, sponsored by BioCryst Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in participants with hereditary angioedema (HAE). Eligible participants will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.
Primary Outcome
An angioedema attack was defined as swelling at any location reported by participant, which had no swelling earlier. Total number of confirmed attacks during the treatment period standardized to a weekly attack-rate to adjust for the total duration of treatment. The attack rate was derived for each participant by treatment period. The weekly attack rate was equal to the total number of confirmed attacks during a treatment period divided by the duration of the treatment (in days) times 7 days.
Interventions
- DRUG Placebo
- DRUG BCX4161
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT02303626 record still lists
NCT02303626 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02303626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02303626 about?
NCT02303626 is a clinical study titled "12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks". This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in participants with hereditary angioedema (HAE). Eligible participants will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of ...
What is the current status of trial NCT02303626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2014-12-17. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02303626?
The interventions under investigation include: Placebo (DRUG), BCX4161 (DRUG).
Who is sponsoring clinical trial NCT02303626?
This trial is sponsored by BioCryst Pharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02303626's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01530373 · 110 participants · Phase 2
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
- NCT02379377 · 110 participants · Phase 1
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
- NCT02411773 · 110 participants · Phase 1
Sympatholysis in Chronic Kidney Disease
- NCT03190941 · 110 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI