Trial · NCT03205995
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Platelet Count (10^9 Platelets/L) Change From Baseline at Week 26 | Week 26 | The primary outcome to be measured is platelet count change from baseline. |
| Secondary | Safety as Measured by Incidences of Adverse Events, Vital Signs, ECG, and Clinical Laboratory Tests | Pre-dose and up to 771 days post-dose | Assessment of safety of OMS721 (narsoplimab) in participants with aHUS by incidence of Adverse Events, clinically significant vital sign abnormalities, ECG abnormalities, and clinical laboratory test abnormalities |
| Secondary | Thrombotic Microangiopathies (TMA) Response | 26 weeks | Complete TMA response defined as normalization of platelet count, normalization of serum lactate dehydrogenase (LDH), and \> 25% decrease in serum creatinine by at least 2 consecutive measures over at least 4 consecutive weeks, within the initial 26-week period |
| Secondary | TMA Event-free Status | 26 weeks | No decrease in platelet count of \> 25% from baseline, no plasma exchange or plasma infusion, and no initiation of new dialysis over at least 12 consecutive weeks, within the initial 26-week period |
| Secondary | Increase in Estimated Glomerular Filtration Rate (eGFR) | 26 weeks | Increase of greater than 15 ml/min/1.73 m2 in eGFR calculated by the modification of diet in renal disease (MDRD) Equation |
| Secondary | Hematological Normalization | 26 weeks | Normalization of platelet count and normalization of serum LDH by 2 consecutive measurements over at least 4 weeks, within the initial 26-week period |
| Secondary | TMA Remission | 26 weeks | Platelet count greater than or equal to 150,000/μL on at least 2 consecutive measures over at least 2 consecutive weeks, within the initial 26-week period |
| Secondary | Incidence of Antidrug Antibodies (ADA) | 771 days post-dose | Incidences of ADA in participants with aHUS, administered OMS721 (narsoplimab) |
| Secondary | Change From Baseline in Serum Creatinine (mg/dL) | 26 weeks | Assessment of subject's change from baseline in serum creatinine. |
| Secondary | Change From Baseline in Serum LDH (U/L) | 26 weeks | Assessment of subject's change from baseline in serum LDH |
| Secondary | Change From Baseline in Haptoglobin (mg/dL) | 26 weeks | Assessment of subject's change from baseline in haptoglobin |
| Secondary | Pharmacokinetics (PK): Trough Plasma Concentration, Lower Limit of Quantification (LLOQ) | Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (RT) (if occurs): RT Days 1-4; Follow-Up at Day 771 | Pharmacokinetics (PK): Trough plasma concentration, lower limit of quantification (LLOQ) |
| Secondary | Pharmacokinetics (PK): Maximum Plasma Concentrations (Cmax) | Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771 | Pharmacokinetics (PK): Maximum plasma concentrations (Cmax) |
| Secondary | Pharmacokinetics (PK): Area Under Time-concentration Curve (AUC) | Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771 | Pharmacokinetics (PK): Area under time-concentration curve (AUC) |
| Secondary | Pharmacodynamics (PD): Inhibition of C3 Activity (%) | Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771 | Pharmacodynamics (PD): Inhibition of C3 activity |
| Secondary | Pharmacodynamics (PD): Inhibition of C4 Activity (%) | Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771 | Pharmacodynamics (PD): Inhibition of C4 activity |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03205995/registered