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AttaCH: A Phase 2, Multicenter, Long-Term, Open Label Extension Trial Evaluating Safety, Tolerability, and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children and Adolescents with Achondroplasia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502202-33-00
Acronym
ASND0039
Enrollment
113
Registered
2023-05-22
Start date
2023-07-06
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achondroplasia in Children and Adolescents

Brief summary

Incidence of treatment emergent adverse events (TEAEs) [Time Frame: Through trial completion], Height Z-scores [Time Frame: Through trial completion]

Detailed description

Annualized growth velocity (AGV) (cm/year), Near final adult height [Time Frame: Through trial completion], Safety assessments: • Laboratory results of safety blood parameters • Vital signs (BP, HR, body temperature) • Abnormal physical examination findings • 12-lead electrocardiogram (ECG) • Tanner stage • Imaging assessments of bone age and bone related safety events (e.g. fracture, skeletal deformities, joint damage, slipped capital femoral epiphysis, avascular necrosis and osteonecrosis) • Tolerability and acceptability [Time Frame: Through trial completion], Plasma concentrations of Total CNP, Free CNP, and mPEG [Time Frame: Through treatment completion], Detection and analysis of anti-drug antibodies (ADAs) [Time Frame: Through trial completion]

Interventions

Sponsors

Ascendis Pharma Growth Disorders A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Incidence of treatment emergent adverse events (TEAEs) [Time Frame: Through trial completion], Height Z-scores [Time Frame: Through trial completion]

Secondary

MeasureTime frame
Annualized growth velocity (AGV) (cm/year), Near final adult height [Time Frame: Through trial completion], Safety assessments: • Laboratory results of safety blood parameters • Vital signs (BP, HR, body temperature) • Abnormal physical examination findings • 12-lead electrocardiogram (ECG) • Tanner stage • Imaging assessments of bone age and bone related safety events (e.g. fracture, skeletal deformities, joint damage, slipped capital femoral epiphysis, avascular necrosis and osteonecrosis) • Tolerability and acceptability [Time Frame: Through trial completion], Plasma concentrations of Total CNP, Free CNP, and mPEG [Time Frame: Through treatment completion], Detection and analysis of anti-drug antibodies (ADAs) [Time Frame: Through trial completion]

Countries

Austria, Denmark, Germany, Ireland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026