Trial · NCT07254000
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Population Pharmacokinetics (PopPK) Model of the Clearance of anakinra in extremely premature neonates from birth, during the 3-week treatment period. | From Baseline up to Day 21 | Point Estimate of Population Total Clearance (CL) of anakinra will be reported. |
| Primary | Population Pharmacokinetics (PopPK) Model of the Volume of Distribution of anakinra in extremely premature neonates from birth, during the 3-week treatment period. | From Baseline up to Day 21 | Point Estimate of Population Volume of Distribution (VD) of anakinra will be reported. |
| Primary | Population Pharmacokinetics (PopPK) Model of the Absorption of Population of subcutaneously administered anakinra in extremely premature neonates from birth, during the 3-week treatment period. | Day 14-21 | Point Estimate of Population Absorption of subcutaneously administered anakinra will be reported. |
| Secondary | Incidence of bronchopulmonary dysplasia | 4 months. | Early efficacy endpoints (exploratory): incidence of bronchopulmonary dysplasia, in comparison to contemporary unit and national statistics. |
| Secondary | Hammersmith infant neurological examination | 6 months | Early efficacy endpoint (exploratory): Hammersmith infant neurological examination; performed at 3-4 months of corrected age, in comparison to contemporary unit and national statistics. |
| Secondary | Incidence of intracranial/intraventricular haemorrhage and peri-ventricular leukomalacia. | 4 months | Early efficacy endpoint (exploratory): incidence of intracranial/intraventricular haemorrhage and peri-ventricular leukomalacia, in comparison to contemporary unit and national statistics. |
| Secondary | Safety of anakinra in extremely premature neonates. | 4 weeks | Safety of anakinra IV and SC in premature neonates, at 3 dosing levels, measured as incidence of safety endpoints in particular late-onset sepsis and necrotizing enterocolitis (compared with contemporary unit and national statistics) as well as neutropenia, thrombocytopenia, acute kidney injury, drug-induced liver injury (per Hy's Law). |
| Secondary | Individual Total Clearance (CL) of anakinra in extremely premature neonates. | From Baseline up to Day 21. | Average of individual model-derived estimates of CL will be reported. |
| Secondary | Individual Volume of Distribution (VD) of anakinra in extremely premature neonates. | Baseline to Day 21. | Average of individual model-derived estimates of VD will be reported. |
| Secondary | Individual Absorption Rate Constant (Ka) of subcutaneously administered anakinra in extremely premature neonates. | Day 14-21. | Average of individual model-derived estimates of Ka will be reported. |
| Secondary | Individual Maximum Serum Concentration (Cmax) of anakinra. | Baseline to Day 21. | Average of individual model-derived estimates of Cmax will be reported. |
| Secondary | Individual Area Under the Concentration-time Curve Within a Dosing Interval (AUCtau) of anakinra. | Baseline to D21. | Average of individual model-derived estimates of AUCtau will be reported. |
| Secondary | Individual Model - derived Ctrough Concentrations of anakinra. | Baseline to D21. | Average of individual model-derived Ctrough concentrations of anakinra will be reported. |
| Other | Feasibility of 3 weeks of anakinra administration to extremely premature neonates from birth, both intravenously and subcutaneously. | 1 month | Feasibility of anakinra IV and SC in premature neonates, at 3 dosing levels, measured as succesful completion of intervention treatment course, including subcutaneous dosing. |
| Other | Influence of anakinra on microbiome. | 3 weeks | Monitoring for lung and gut microbiome changes during the treatment course by collection and analysis of bronchoalveolar lavage fluid (in intubated infants), nasopharyngeal swabs, and stool. |
| Other | Pharmacokinetic (PK)/Pharmacodynamic (PD) Model of the Effect of anakinra Systemic Exposure on clinical endpoints. | 4 months | Point Estimate of population IC50 of anakinra associated with a reduction in incidence of early efficacy endpoints (exploratory), including bronchopulmonary dysplasia, intracranial/intraventricular haemorrhage \& peri-ventricular leukomalacia, and Hammersmith infant neurological examination; performed at 3-4 months of corrected age. |
| Other | Pharmacokinetic (PK)/Pharmacodynamic (PD) Model of the Effect of anakinra Systemic Exposure on biomarkers of the inflammatory cascade. | 4 Months. | Point Estimate of population IC50 of anakinra, i.e. the drug concentration required to produce 50% of maximal inhibition of the IL-1-driven inflammatory cascade. Biomarkers investigated will include cellular proteomic biomarkers of inflammatory activity and inhibition, including lymphoid and myeloid cell polarisation and activation as well as responsiveness to stimulants such as lipopolysaccharide (LPS) and PMA/ionomycin during the treatment course. |
| Other | Pharmacokinetic (PK)/Pharmacodynamic (PD) Model of the Effect of anakinra Systemic Exposure on adverse effects. | Baseline to Day 21. | Point Estimate of population EC50 of anakinra, i.e. the drug concentration associated with exploratory safety endpoints including late-onset sepsis, necrotizing enterocolitis, neutropenia, thrombocytopenia, acute kidney injury, drug-induced liver injury (per Hy's Law). |
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/NCT07254000/registered