Trial · NCT07559513
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Treatment-Emergent Adverse Event (TEAEs) | Baseline to week 56 | |
| Primary | Severity of TEAEs | Baseline to week 56 | |
| Primary | Concentrations of functional garetosmab in serum | Through week 56 | |
| Secondary | Total volume of new Heterotopic Ossification (HO) lesions | At week 28 and week 56 | |
| Secondary | Number of new HO lesions | At week 28 and week 56 | |
| Secondary | Occurrence of new HO lesions | At week 28 and week 56 | |
| Secondary | Number of clinician-assessed flare-ups | Through week 28 and week 56 | |
| Secondary | Occurrence of clinician-assessed flare-ups | Through week 28 and week 56 | |
| Secondary | Change from baseline in total volume of HO lesions | At week 28 and week 56 | |
| Secondary | Change from baseline in Tanner puberty scale | At week 28 and week 56 | Tanner puberty scale or stages: Staging of sexual development is graded on a 5-point ordinal scale ranging from 1 (prepubertal) to 5 (adultlike) for female breast development, male external genitals, and pubic hair |
| Secondary | Characteristics of menstrual cycles for female participants who reached menarche | Over 28 weeks and 56 weeks | |
| Secondary | Height-for-age Z-Scores according to the World Health Organization (WHO) Growth Reference Data for Children | Through week 56 | Participants 5-19 years of age Z-score represents standardized measure of how far an individual deviated from study cohort average at baseline. A higher Z-score reflects better performance. |
| Secondary | Change from baseline in knee height | At week 28 and week 56 | |
| Secondary | Concentrations of total activin A in serum | Through week 56 | |
| Secondary | Occurence of Anti-Drug Antibody (ADA) to garetosmab | Through week 56 | |
| Secondary | Magnitude of ADA to garetosmab | Through week 56 | |
| Secondary | Change from baseline in hearing function as assessed by audiometry | At week 28 and week 56 | |
| Secondary | Change from baseline in Pediatric Quality of Life inventory (PedsQL) scores | At week 28 and week 56 | Age-appropriate PedsQL Generic Core Scales will be used to measure HRQoL in children and adolescents. Response options include 5-point Likert scale (or 3-point Likert scale for the young children self-report) for each item asking about experience within the past week. Global scores are transformed to a 0 to 100 scale with higher scores indicating better quality of life. |
| Secondary | Acceptability or tolerability assessment via exit interview | Up to week 52 | Each interview will be conducted by trained external interviewers following a semi-structured interview guide of questions for the participants about their overall experience in the trial. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07559513/registered