Trial · NCT03158948
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Adverse events experienced until D28 (End of study visit) | Analyses were performed in the Safety Set composed of all randomized patients who received at least any dose of the study drug (nangibotide or placebo). Adverse events: Summary statistics of treatment emergent adverse events (TEAEs). Clinical events, including death, related to severe sepsis and sepsis complications were exempt from SAE reporting, unless the investigator deemed the event to be related to the administration of the study drug. |
| Primary | Systolic Blood Pressure (SBP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | Systolic blood pressure measured by sphygmomanometer at study site. Median SBP at each visit is summarized by treatment group. |
| Primary | Diastolic Blood Pressure (DBP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | Median DBP at each visit is summarized by treatment group. |
| Primary | Median Arterial Pressure (MAP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | MAP at each visit is summarized by treatment group. |
| Primary | Heart Rate | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). | Median heart rate at each visit is summarized by treatment group. |
| Primary | Temperature | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). | Median temperature at each visit is summarized by treatment group. |
| Primary | Electrocardiogram | Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS). | Abnormal and emergent clinically significant electrocardiogram were summarized for each group. |
| Primary | Anti-Drug Antibodies (ADA Dimer) | Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients. | Anti-Drug Antibodies test was performed for all patients. |
| Primary | Anti-Drug Antibodies (ADA Monomer) | Anti-Drug Antibodies test were measured at D0, D10 and D28. | Anti-Drug Antibodies test was performed for all patients. |
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI | As no pharmacokinetic sample was planned just after the loading dose, maximum observed nangibotide plasma concentration (Cmax) was in the same magnitude as steady-state concentration during the maintenance infusion, calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study (Cavg). |
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI | Time to reach the maximum observed nangibotide plasma concentration (h) was measured for all groups. |
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration Clast was calculated using the log-linear trapezoidal method. |
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: Cavg | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI | Steady-state concentration during the maintenance infusion was calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study. |
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: CL | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI | Systemic clearance was calculated as the ratio between the infusion rate during the maintenance infusion and Cavg. |
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.
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