Trial · NCT03989947
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | "Through study completion, an average of 5 years" | Number of study participants with treatment-emergent adverse events or serious adverse events |
| Primary | Evaluate change in height/length z-score in children with ACH treated with BMN 111 | "Through study completion, an average of 5 years" | |
| Secondary | Evaluate the change from baseline of mean annualized growth velocity (AGV) | "Through study completion, an average of 5 years" | |
| Secondary | Characterize maximum concentration (Cmax) of BMN 111 in plasma | "Through study completion, an average of 5 years" | |
| Secondary | Characterize the area under the plasma concentration time-curve from time 0 to infinity (AUC0-∞) | "Through study completion, an average of 5 years" | |
| Secondary | Characterize the elimination half-life of BMN 111 (t½) | "Through study completion, an average of 5 years" | |
| Secondary | Characterize the apparent clearance of drug | "Through study completion, an average of 5 years" | |
| Secondary | Characterize the apparent volume of distribution based upon the terminal phase (Vz/F) | "Through study completion, an average of 5 years" | |
| Secondary | Characterize the amount of time BMN 111 is present at maximum concentration (Tmax) | "Through study completion, an average of 5 years" | |
| Secondary | Evaluate the change from baseline on body proportion ratios of the extremities | "Through study completion, an average of 5 years" | |
| Secondary | Effect of BMN 111 on bone morphology and quality by XRay | "Through study completion, an average of 5 years" | |
| Secondary | The effect of BMN 111 on bone morphology/quality will be assessed by measuring bone mineral density via Dual X-ray Absorptiometry | "Through study completion, an average of 5 years" | |
| Secondary | Potential Changes in health-related quality of life as measured by the quality of life in Short- statured youth | "Through study completion, an average of 5 years" | Evaluate the long-term effect of BMN 111 on health-related quality of life, developmental status and functional independence, using age-specific QoL and functional independence questionnaires (Bayley-III, WeeFIM, ITQOL, QoLISSY, PedsQL, Child Behavior Checklist 1.5-5 \[CBCL 1.5-5\], Child Behavior Checklist 6-18 \[CBCL 6-18\]). |
| Secondary | BMN 111 activity will be assessed by measuring bone and collagen metabolism | "Through study completion, an average of 5 years" | |
| Secondary | Describe the incidence of surgical and medical interventions related to achondroplasia | "Through study completion, an average of 5 years" | |
| Secondary | Assess effect on sleep disordered breathing by polysomnography in patients up to 5 years old. | "Through study completion, an average of 1 year" | |
| Secondary | Evaluate the effect of BMN 111 on skull and brain morphology, including foramen magnum, ventricular and brain parenchymal dimensions by MRI in patients up to 3 years old. | "Through study completion, an average of 1 year" |
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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