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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001189-13 | EudraCT Number |
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The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.
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Approximately 63 participants will be randomized to one of three doses to receive Recifercept either
Participants will will attend the clinic at baseline and at Day 1, 4, 8, 15, 29 & then Month 2, 3 6, 9 & 12. Assessments include safety, blood sampling, physical examination, vital signs, anthropometric body measurements & patient/caregiver quality of life questionnaires
Participants will received treatment with Recifercept for 12 months. All participants who complete the study and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll into an open-label extension (OLE) study.
A PK cohort will include 12 participants who will randomly receive a single dose of 3 mg/kg of Phase 2 study (process 1c) formulation and a single dose of 3 mg/kg of the proposed Phase 3 (process 2) study formulation in a cross over study. Dose of the cohort could be changed due to emerging safety and efficacy data in the study.
This is a phase 2 randomized, 3 arm (3 active doses of Recifercept), parallel group dose finding study of safety, tolerability, PK and efficacy
The total number of participants is 63 in 2 age straified cohorts of 0-2 years and 6-10 years old.
The study will enroll approximately 54 children with achondroplasia aged 2-10 years (inclusive) who will be enrolled and randomized to receive one of three doses of recifercept
A total of 18 participants will be enrolled per dose 18 per dosesuch that at least 15 participants per dose are evaluable. An interim analysis is planned when at least 15 participants per dose aged ≥2 to <11 years have received 6 months of treatment with recifercept. eDMC will review safety, PK and efficacy data to confirm ongoing positive benefit:risk in participants.
Additionally, an exploratory cohort of approximately 9 children with achondroplasia, ages 0-2 years, will be enrolled later in the study (n=3 per dose).
Enrollment will follow an age and dose-staggered approach (descending age and ascending dose) with review of safety and PK data by the study team before progression to the next enrollment block If certain pre-defined safety signals occur then a meeting of the eDMC will be convened to make a decision on progression of enrollment. The PK data collected in block A will be used in the PopPK model (developed using healthy adult data) to confirm the dosing for younger children (ie, ≥2 to <6 years and 0-<2 years).
Participants will will attend the clinic at baseline and at Day 1, 4, 8, 15, 29 & then Month 2, 3 6, 9 & 12. Assessments include safety, blood sampling, physical examination, vital signs, anthropometric body measurements & patient/caregiver quality of life questionnaires
All participants will receive recifercept for 12 months. All participants who complete the study and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll into an open-label extension (OLE) study.
PK Cohort:
Multiple changes have been made in the manufacturing process of the drug product (process 2) which will be used in Phase 3. Therefore, an additional PK cohort (at selected sites only) has been added, to evaluate the PK of Phase 2 formulation (process 1c) and Phase 3 formulation (process 2).
PK Cohort:
At selected sites only, an additional PK cohort has been added to evaluate the PK of two recifercept formulations. A total of 12 children with achondroplasia aged 2- <11 years will be enrolled in the PK cohort (6 in each treatment sequence). Each participant will receive 2 treatments (3 mg/kg Phase 2 formulation [process 1c] and 3 mg/kg Phase 3 formulation [process 2]) in a randomized manner. Dose of the cohort could be changed due to emerging safety and efficacy data in the study.
PK samples collected following each dose will be analyzed to evaluate the exposures of two formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Low Dose |
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| Medium Dose | Experimental | Medium Dose |
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| High Dose | Experimental | High Dose |
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| PK Phase 2 Formulation | Experimental | Phase 2 formulation [process 1c] 3mg/kg |
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| PK Phase 3 Formulation | Experimental | Phase 3 formulation [process 2] 3mg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recifercept | Biological | Recifercept |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 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). | The first dose up to 28 to 35 days after the last dose of study intervention (13 months) |
| Least Square Mean of Change From Baseline Height Growth at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulse Rate at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocean Sleep Medicine | Aliso Viejo | California | 92656 | United States | ||
| Ocean Sleep Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38685585 | Derived | Qiao W, Boucher M, Slade A, Dawra VK. Natural disease course modeling of achondroplasia to evaluate the efficacy of recifercept in the absence of a placebo control arm in phase II study. CPT Pharmacometrics Syst Pharmacol. 2024 Jul;13(7):1103-1116. doi: 10.1002/psp4.13143. Epub 2024 Apr 29. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 60 participants were enrolled, of which, 58 participants were assigned to treatment and 2 participants were not randomized, Out of 58 participants, 57 participants were treated. Note: The pharmacokinetics (PK) study cohort was not enrolled due to early study termination,
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| ID | Title | Description |
|---|---|---|
| FG000 | Recifercept 1 mg/kg QW | Children participants were enrolled and randomized to receive recifercept 1 mg/kg once weekly (QW) for 12 months. |
| FG001 | Recifercept 2 mg/kg BIW | Children participants were enrolled and randomized to receive recifercept 2 mg/kg twice weekly (BIW) for 12 months. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2022 | Jan 15, 2024 |
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Anthropometric Measurements Assessor
| Change From Baseline in Respiratory Rate at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Blood Pressure at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Temperature at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Number of Participants With Abnormal Physical Examination Findings at 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. | Month 3, Month 6, Month 9, and Month 12 |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 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). | Baseline to Month 12 |
| Pre-Dose Serum Concentration (Ctrough) of Recifercept | Ctrough was defined as pre-dose serum concentration during dosing and observed directly from data. | Pre-dose on Day(s) 4, 8, 15, 29, 61, 91, 183, 273, 365 |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of Recifercept | The immunogenicity was measured by presence of ADA and NAb in participants treated with recifercept and summarized by dose regimen. | The first dose up to 28 to 35 days after the last dose of study intervention (13 months) |
| Change From Baseline in Sitting/Standing Height Ratio at Month 3, Month 6, Month 9, and Month 12 | Sitting/standing height ratio was the ratio of sitting height to standing height. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Least Square Mean of Change From Baseline Arm Span to Standing Height/Length Difference at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Knee Height : Lower Segment Ratio at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Occipito-Frontal Circumference at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Occipito-Frontal to Occipito-Mid-Face Ratio at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Height Standard Deviation Score (Z-Score) at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Fixed Flexion Angles at Elbow at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Body Mass Index (BMI) at 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. | Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change From Baseline in Waist : Chest Circumference Ratio at 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. | Baseline, Month 9, and Month 12 |
| Change From Baseline in Apnea-Hypopnea Index (AHI) at 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. | Baseline and Month 12 |
| Change From Baseline in Desaturation Index at Month 12 | Desaturation index is one of the polysomnography parameters to assess obstructive sleep apnea. It refers to the average number of desaturation episodes occurring per hour, where desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥3% (over the last 120 seconds) that lasts for at least 10 seconds. | Baseline and Month 12 |
| Change From Baseline in Polysomnography Other Parameters at Month 12 | Polysomnography refers to a systematic process used to collect physiologic parameters during sleep. Polysomnography other parameters included total sleep time spent with oxygen saturation (SaO2) < 90% (T90), total sleep time spent with end-tidal carbon dioxide (EtCO2) >50 mm Hg. | Baseline and Month 12 |
| Change From Baseline in SaO2 Nadir at Month 12 | SaO2 measures the percentage of oxyhemoglobin (oxygen-bound hemoglobin) in the blood. SaO2 nadir refers to lowest SaO2. | Baseline and Month 12 |
| Irvine |
| California |
| 92604 |
| United States |
| MemorialCare Sleep Disorders Center at Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Nemours Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Murdoch Children's Research Institute | Melbourne | Victoria | 3052 | Australia |
| Murdoch Children's Research Institute | Parkville | Victoria | 3052 | Australia |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Universitaire Ziekenhuizen Leuven (UZ Leuven) | Leuven | 3000 | Belgium |
| DanTrials ApS | Copenhagen NV | DK-2400 | Denmark |
| Fondazione Policlinico Universitario Agostino - Gemelli IRCCS | Roma | 00168 | Italy |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Centro Hospitalar e Universitário de Coimbra - Hospital Pediátrico | Coimbra | 3000-602 | Portugal |
| Hospital Vithas San Jose | Vitoria-Gasteiz | Alava | 01008 | Spain |
| FG002 | Recifercept 1.5 mg/kg QD | Children participants were enrolled and randomized to receive recifercept 1.5 mg/kg once daily (QD) for 12 months. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline analysis population included all participants who received at least one dose of recifercept.
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| ID | Title | Description |
|---|---|---|
| BG000 | Recifercept 1 mg/kg QW | Children participants were enrolled and randomized to receive recifercept 1 mg/kg once weekly (QW) for 12 months. |
| BG001 | Recifercept 2 mg/kg BIW | Children participants were enrolled and randomized to receive recifercept 2 mg/kg twice weekly (BIW) for 12 months. |
| BG002 | Recifercept 1.5 mg/kg QD | Children participants were enrolled and randomized to receive recifercept 1.5 mg/kg once daily (QD) for 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 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). | Analysis population included all participants who received at least 1 dose of recifercept. | Posted | Count of Participants | Participants | The first dose up to 28 to 35 days after the last dose of study intervention (13 months) |
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| Primary | Least Square Mean of Change From Baseline Height Growth at 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. | Analysis population included all participants who received at least 1 dose of recifercept. | Posted | Least Squares Mean | 95% Confidence Interval | Ratio | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Pulse Rate at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | beats per minute (BPM) | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Respiratory Rate at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | breaths/min | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Blood Pressure at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Temperature at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | Degree Celsius (°C) | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Number of Participants With Abnormal Physical Examination Findings at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Count of Participants | Participants | Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 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). | Analysis population included all participants who received at least 1 dose of recifercept. | Posted | Count of Participants | Participants | Baseline to Month 12 |
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| Secondary | Pre-Dose Serum Concentration (Ctrough) of Recifercept | Ctrough was defined as pre-dose serum concentration during dosing and observed directly from data. | Analysis population included all participants who received at least 1 dose of recifercept and had at least one evaluable concentration. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | nanograms per millilitre (ng/mL) | Pre-dose on Day(s) 4, 8, 15, 29, 61, 91, 183, 273, 365 |
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| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of Recifercept | The immunogenicity was measured by presence of ADA and NAb in participants treated with recifercept and summarized by dose regimen. | Analysis population included all participants who received at least 1 dose of recifercept. | Posted | Count of Participants | Participants | The first dose up to 28 to 35 days after the last dose of study intervention (13 months) |
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| Secondary | Change From Baseline in Sitting/Standing Height Ratio at Month 3, Month 6, Month 9, and Month 12 | Sitting/standing height ratio was the ratio of sitting height to standing height. | Analysis population included all participants who received at least 1 dose of recifercept. The "Overall Number of Participants Analyzed" was based on age 2-10 years at baseline. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | Ratio | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| 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 | Arm span to standing height/length difference was the difference between arm span and standing height. | Analysis population included all participants who received at least 1 dose of recifercept. | Posted | Least Squares Mean | 95% Confidence Interval | centimeter (cm) | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Knee Height : Lower Segment Ratio at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | Ratio | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Occipito-Frontal Circumference at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | cm | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Occipito-Frontal to Occipito-Mid-Face Ratio at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | Ratio | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Height Standard Deviation Score (Z-Score) at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Overall Number of Participants Analyzed" was based on age 2-10 years at baseline. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | SDS | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Fixed Flexion Angles at Elbow at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | degrees (°) | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Body Mass Index (BMI) at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Waist : Chest Circumference Ratio at 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. | Analysis population included all participants who received at least 1 dose of recifercept. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | Ratio | Baseline, Month 9, and Month 12 |
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| Secondary | Change From Baseline in Apnea-Hypopnea Index (AHI) at 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. | Analysis population included all participants who received at least 1 dose of recifercept and with a documented current diagnosis of sleep disordered breathing at enrollment. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | events per hour | Baseline and Month 12 |
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| Secondary | Change From Baseline in Desaturation Index at Month 12 | Desaturation index is one of the polysomnography parameters to assess obstructive sleep apnea. It refers to the average number of desaturation episodes occurring per hour, where desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥3% (over the last 120 seconds) that lasts for at least 10 seconds. | Analysis population included all participants who received at least 1 dose of recifercept and with a documented current diagnosis of sleep disordered breathing at enrollment. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | desaturations per hour | Baseline and Month 12 |
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| Secondary | Change From Baseline in Polysomnography Other Parameters at Month 12 | Polysomnography refers to a systematic process used to collect physiologic parameters during sleep. Polysomnography other parameters included total sleep time spent with oxygen saturation (SaO2) < 90% (T90), total sleep time spent with end-tidal carbon dioxide (EtCO2) >50 mm Hg. | Analysis population included all participants who received at least 1 dose of recifercept and with a documented diagnosis of sleep-disordered breathing at enrollment. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | percentage (%) of total sleep time | Baseline and Month 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SaO2 Nadir at Month 12 | SaO2 measures the percentage of oxyhemoglobin (oxygen-bound hemoglobin) in the blood. SaO2 nadir refers to lowest SaO2. | Analysis population included all participants who received at least 1 dose of recifercept and with a documented diagnosis of sleep-disordered breathing at enrollment. The "Number Analyzed" in a row was based on actual analyzed participants at each visit. | Posted | Mean | Standard Deviation | percentage (%) of oxyhemoglobin | Baseline and Month 12 |
|
The first dose up to 28 to 35 days after the last dose of study intervention (13 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recifercept 1 mg/kg QW | Children participants were enrolled and randomized to receive recifercept 1 mg/kg once weekly (QW) for 12 months. | 0 | 20 | 1 | 20 | 16 | 20 |
| EG001 | Recifercept 2 mg/kg BIW | Children participants were enrolled and randomized to receive recifercept 2 mg/kg twice weekly (BIW) for 12 months. | 0 | 19 | 0 | 19 | 19 | 19 |
| EG002 | Recifercept 1.5 mg/kg QD | Children participants were enrolled and randomized to receive recifercept 1.5 mg/kg once daily (QD) for 12 months. | 0 | 18 | 0 | 18 | 16 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site hypersensitivity | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Otitis media bacterial | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood albumin increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood bicarbonate increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 26.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Antisocial behaviour | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cafe au lait spots | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDRA 26.0 | Non-systematic Assessment |
|
The PK study cohort was not enrolled due to early study termination, therefore, the data of the PK cohort were not collected.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2022 | Jan 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000130 | Achondroplasia |
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010009 | Osteochondrodysplasias |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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