| Trial ID: | L0770 |
| Source ID: | NCT03358030
|
| Associated Drug: |
Isis 416858
|
| Title: |
A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis
|
| Acronym: |
EMERALD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03358030/results
|
| Conditions: |
End-stage Renal Disease (ESRD)
|
| Interventions: |
DRUG: ISIS 416858|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Participants With Major Bleeding (MB) and Clinically Relevant Non-Major Bleeding (CRNMB), MB was defined as one of the following: Fatal bleeding; symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular if in a major joint, or pericardial, or intramuscular with compartment syndrome, clinically overt bleeding leading to transfusion of greater than or equal to (\>=) 2 units of packed red blood cells or whole blood or a fall in hemoglobin of 20 grams per liter (g/L) (1.24 millimoles per liter \[mmol/L\]) or more within 24 hours. CRNMB was defined as overt bleeding not meeting the criteria for MB but that resulted, in either medical examination, intervention, or had clinical consequences for a participant., Up to Day 260 | Other: Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT), Baseline (Day 1) up to Day 260|Percent Change From Baseline in Factor XI (FXI) Activity, Baseline (Day 1) up to Day 260|Number of Participants With Laboratory Abnormalities Related to Platelet Count, Participants were assessed based on pre-defined criteria in the protocol for platelet count abnormality: 100 - less than (\<)140, 75 - \<100, 50 - \<75, 25 - \<50 and \< 25 thousands per cubic millimeter (K/mm\^3) based on investigator's discretion., Up to Day 260|Number of Participants With Laboratory Abnormalities - Alanine Transaminase (ALT) and Aspartate Aminotransferase (AST), Participants were assessed based on pre-defined criteria in protocol for abnormality in ALT and AST values: Confirmed ALT (serum glutamic pyruvic transaminase \[SGPT\]); greater than (\>) 3\*Upper limit of normal range (ULN), \>5\*ULN and confirmed AST (serum glutamic-oxaloacetic transaminase \[SGOT\]); \>3\*ULN and \>5\*ULN. A confirmed value was based on a consecutive lab value within 7 days of the initial value. If that value was in the same or worse category the initial value was confirmed. If the consecutive value was in a better category then the initial value was confirmed using the consecutive value category. If there were multiple results on the same day, no matter from the same lab vendor or different lab vendors, then the worst value was used in the analysis. Abnormality in laboratory parameter was based on investigator's discretion., Up to Day 260|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Up to Day 260|Percent Change From Baseline in Factor XI (FXI) Antigen Levels, Baseline (Day 1) up to Day 260
|
| Sponsor/Collaborators: |
Sponsor: Ionis Pharmaceuticals, Inc. | Collaborators: Bayer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
213
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2017-12-26
|
| Completion Date: |
2019-07-10
|
| Results First Posted: |
2023-01-20
|
| Last Update Posted: |
2023-01-20
|
| Locations: |
Ionis Investigative Site, Santiago De Compostela, A Coruna, 15706, Spain|Ionis Investigative Site, Alcalá De Henares, Madrid, 28805, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT03358030
|
