Clinical Trials
74
5 active
Approvals
28
Total approvals
Agencies
2
Regulatory bodies
Founded
1983
Active, not recruiting
5
6.8%
Completed
48
64.9%
Recruiting
8
10.8%
Terminated
12
16.2%
Withdrawn
1
1.4%
- The University of Colorado Anschutz Medical Campus received a $29 million grant from Octapharma to lead the EFFECT Trial, evaluating early fibrinogen replacement in trauma patients with life-threatening bleeding. - The multicenter randomized trial will enroll 800 participants across 12 top-tier trauma centers, representing the first U.S. clinical trial to rigorously evaluate fibrinogen concentrate as a frontline trauma intervention. - The study aims to address hemorrhage, the primary cause of preventable death after traumatic injury, by targeting fibrinogen depletion which occurs first among coagulation factors. - Results could transform trauma resuscitation protocols for both civilian and military care, potentially influencing global trauma treatment guidelines.
- Octapharma's phase 3 trial of PANZYGA for pediatric acute-onset neuropsychiatric syndrome (PANS) missed its primary endpoint of reducing obsessive-compulsive symptoms measured by CY-BOCS score. - The study achieved statistical significance on the key secondary endpoint of Clinical Global Impression (CGI-I) score, showing clinically relevant improvement in overall disease burden (p-value = 0.017). - PANZYGA demonstrated a 31.1% mean improvement in CY-BOCS scores compared to 12.1% with placebo, though the difference was not statistically significant (p-value = 0.072). - The crossover analysis revealed continued symptom improvement in patients who initially received PANZYGA, suggesting sustained therapeutic effects from the immunoglobulin treatment.
