Atypical Hemolytic Uremic Syndrome Clinical Trial
Official title:
A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents
The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response (ADA).
This is a Phase 3, multicenter study of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The uncontrolled, open-label study will evaluate the effect of OMS721 in subjects with plasma therapy-resistant aHUS and plasma therapy-responsive aHUS. This study has four periods: Screening, Treatment Induction, Treatment Maintenance, and Follow-up. Approximate enrollment is 80 subjects. An interim analysis will be performed after 40 subjects have completed 26 weeks of treatment for potential registration. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03605511 -
TTP and aHUS in Complicated Pregnancies
|
||
| Withdrawn |
NCT03303313 -
A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome
|
Phase 2 | |
| Recruiting |
NCT04861259 -
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
|
Phase 3 | |
| Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
| Terminated |
NCT02614898 -
Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment
|
||
| Completed |
NCT02574403 -
Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS
|
Phase 4 | |
| Recruiting |
NCT04958265 -
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
|
Phase 3 | |
| Recruiting |
NCT05795140 -
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
|
Phase 3 | |
| Completed |
NCT00844844 -
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS
|
Phase 2 | |
| Completed |
NCT00844545 -
Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS
|
Phase 2 | |
| Terminated |
NCT01522170 -
aHUS Observational Long Term Follow-Up
|
N/A | |
| Terminated |
NCT02464891 -
Complement Inhibition in aHUS Dialysis Patients
|
Phase 2 | |
| Withdrawn |
NCT02626663 -
The Role of Microparticles as a Biomarker
|
||
| Recruiting |
NCT01793168 -
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
|
||
| Completed |
NCT00838513 -
Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS)
|
Phase 2 | |
| Completed |
NCT00844428 -
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS
|
Phase 2 | |
| Withdrawn |
NCT03999840 -
Eculizumab to Cemdisiran Switch in aHUS
|
Phase 2 | |
| Recruiting |
NCT04889430 -
Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy
|
Phase 3 | |
| Recruiting |
NCT05935215 -
Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
|
Phase 3 | |
| Recruiting |
NCT05996731 -
Developing a Pipeline to Employ RNA-Seq as a Complementary Diagnostic Tool in Rare Diseases
|
N/A |