Trial · NCT03205995
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Platelet Count (10^9 Platelets/L) Change From Baseline at Week 26 | Week 26 | Any patent who received drug | 10^9 platelets/L | MEDIAN |
| 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 | The safety population includes all participants who received any amount of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Thrombotic Microangiopathies (TMA) Response | 26 weeks | Any patient who received drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TMA Event-free Status | 26 weeks | Any patient who received drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Increase in Estimated Glomerular Filtration Rate (eGFR) | 26 weeks | Any patient who received drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hematological Normalization | 26 weeks | Any patient who received drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TMA Remission | 26 weeks | Any patient who received drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Antidrug Antibodies (ADA) | 771 days post-dose | Any patient who received drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Serum Creatinine (mg/dL) | 26 weeks | Any patient who received drug | mg/dL | MEDIAN |
| SECONDARY | Change From Baseline in Serum LDH (U/L) | 26 weeks | Any patient who received drug. | U/L | MEDIAN |
| SECONDARY | Change From Baseline in Haptoglobin (mg/dL) | 26 weeks | Any patient who received drug. | mg/dL | MEDIAN |
| 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 trough plasma concentrations are provided on the pre-dose levels for the six patients enrolled. | ng/mL | MEAN |
| 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 | The observed Cmax values on the 6 patients have been provided. | ng/mL | MEDIAN |
| 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 | PK modeling for calculating the AUC was not performed because the study was not completed. | ||
| 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 | Any patient who received drug and measurable C3 activity. | Inhibition of C3 activity (%) | MEDIAN |
| 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 | Any patient who received drug and measurable C4 activity. | Inhibition of C4 activity (%) | MEDIAN |
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/outcomes