drugset / Trial / NCT04147871

Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children

NCT04147871 ↗

Phase 2/3 Withdrawn Advicenne Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability, and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children.

Timeline

Start
2024-03-01
Primary completion
2025-05-01
Completion
2025-06-01

Outcome

Outcome not reported

Stopped (Business): “Unspecified business decision/strategic reason”

Drugs

EvaluationDrugModalityDoseRoute
Comparator ADV7103 Unknown 1.5 meq —
Comparator ADV7103 Unknown 3 meq —
Comparator ADV7103 Unknown 4.5 meq —

Indications