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Study Evaluating Patients With Cystinuria

NCT04137978 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2024-03-12

No results posted yet for this study

Summary

This is an open label, multicentre study, evaluating the safety, tolerability, efficacy, compliance and acceptability of alkalising treatments at long-term in patients with cystinuria.

Conditions

  • Cystinuria

Interventions

DRUG

ADV7103

Patients receive ADV7103 twice a day at optimal dose.

DRUG

Standard of Care

Cohort of patients with cystinuria, matching-pair for age category to the patients of ADV7103 Cohort, will receive their own alkalinising treatment (SoC) taken at the usual dose and frequency and will follow their usual first intention treatment (hydration and diet) for a 2-year-period.

Sponsors & Collaborators

  • Advicenne Pharma

    lead INDUSTRY

Principal Investigators

  • Luc-André Granier, M.D. · Advicenne Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-06-30
Completion
2025-08-31

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137978 on ClinicalTrials.gov