Trial · NCT04638153
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | The first dose up to 28 to 35 days after the last dose of study intervention (13 months) | Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. Relatedness to recifercept was assessed by the investigator (Yes/No). |
| Primary | Least Square Mean of Change From Baseline Height Growth at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Height growth was defined as the ratio of observed change from baseline in standing height to the expected change from baseline in the reference population. |
| Secondary | Change From Baseline in Pulse Rate at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Pulse rate measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones) where possible (with consideration of the age of the child). Pulse rate was summarized by treatment in accordance with the sponsor reporting standards. |
| Secondary | Change From Baseline in Respiratory Rate at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Respiratory rate was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Respiratory rate was summarized by treatment in accordance with the sponsor reporting standards. |
| Secondary | Change From Baseline in Blood Pressure at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Blood pressure measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones) where possible (with consideration of the age of the child). Supine systolic blood pressure (SBP) and diastolic blood pressure (DBP) were summarized by treatment in accordance with the sponsor reporting standards. |
| Secondary | Change From Baseline in Temperature at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Temperature was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Temperature measurements were summarized by treatment in accordance with the sponsor reporting standards. |
| Secondary | Number of Participants With Abnormal Physical Examination Findings at Month 3, Month 6, Month 9, and Month 12 | Month 3, Month 6, Month 9, and Month 12 | A physical examination included, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal systems and skin. Physical examination assessments were summarized by treatment in accordance with the sponsor reporting standards. |
| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Baseline to Month 12 | Participants with laboratory abnormalities that met pre-specified criteria included following parameters: hematology (corpuscular volume, corpuscular hemoglobin, corpuscular hemoglobin concentration, platelet, leukocytes, lymphocytes, neutrophils, eosinophils, and monocytes), and chemistry (bilirubin, alkaline phosphatase, albumin, urea nitrogen, urate, potassium, phosphate, bicarbonate). |
| Secondary | Pre-Dose Serum Concentration (Ctrough) of Recifercept | Pre-dose on Day(s) 4, 8, 15, 29, 61, 91, 183, 273, 365 | Ctrough was defined as pre-dose serum concentration during dosing and observed directly from data. |
| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of Recifercept | The first dose up to 28 to 35 days after the last dose of study intervention (13 months) | The immunogenicity was measured by presence of ADA and NAb in participants treated with recifercept and summarized by dose regimen. |
| Secondary | Change From Baseline in Sitting/Standing Height Ratio at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Sitting/standing height ratio was the ratio of sitting height to standing height. |
| Secondary | Least Square Mean of Change From Baseline Arm Span to Standing Height/Length Difference at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Arm span to standing height/length difference was the difference between arm span and standing height. |
| Secondary | Change From Baseline in Knee Height : Lower Segment Ratio at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Knee height : lower segment ratio was the ratio of knee to heel length to the difference between standing height and sitting height. |
| Secondary | Change From Baseline in Occipito-Frontal Circumference at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Head circumference or the occipito-frontal circumference is the greatest of the cranial dimensions which passes around the forehead anteriorly and the external occipital protruberance posteriorly. It is a routine part of the physical examination of a child and is of great importance in detecting abnormal patterns of cranial growth. Occipito-frontal circumference data were summarized for each treatment arm. |
| Secondary | Change From Baseline in Occipito-Frontal to Occipito-Mid-Face Ratio at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Ratio of occipito-frontal distance to occipito-mid-face measurements was summarized for each treatment arm. |
| Secondary | Change From Baseline in Height Standard Deviation Score (Z-Score) at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Height Standard Deviation Score (SDS) (z-score) was calculated as the difference between mean observed standing height at each visit and mean value of reference population divided by standard deviation of reference population. SDS indicates how similar the participant was to the reference population. |
| Secondary | Change From Baseline in Fixed Flexion Angles at Elbow at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Fixed flexion angles at elbow data were presented for each treatment arm. An average of a participant's elbow extension measurements over a visit was computed. |
| Secondary | Change From Baseline in Body Mass Index (BMI) at Month 3, Month 6, Month 9, and Month 12 | Baseline, Month 3, Month 6, Month 9, and Month 12 | Body Mass Index (BMI) = Weight (kg)/\[(Standing Height (m))\^2\]. Standing height and weight were averaged over a visit before BMI was computed. |
| Secondary | Change From Baseline in Waist : Chest Circumference Ratio at Month 9 and Month 12 | Baseline, Month 9, and Month 12 | Waist : Chest Ratio = Waist Circumference / Chest Circumference. Waist and chest circumference were averaged over a visit before waist : chest circumference ratio was computed. |
| Secondary | Change From Baseline in Apnea-Hypopnea Index (AHI) at Month 12 | Baseline and Month 12 | The apnea-hypopnea index (AHI) is the average of the apneic and hypopneic episodes per hour of sleep, which is measured to assess obstructive sleep apnea (OSA). An AHI score of 1 to 4.9 events/hour is mild OSA, 5 to 9.9 events/hour is moderate, and more than 9 events/hour is severe in pediatric population. |
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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