WHO ICTRP trial
A clinical study with for objective to evaluate the safety, tolerability…
EUCTR2017-002068-42-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2017-002068-42-BE |
|---|---|
| Public title | A clinical study with for objective to evaluate the safety, tolerability, efficacy, compliance and acceptability of ADV7103 in patients with cystinuria |
| Scientific title | Open label, multicentre study, evaluating the safety, tolerability, efficacy, compliance and the acceptability of alkalising treatments at long-term in patients with cystinuria |
| Primary sponsor | Advicenne |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;Belgium |
| Conditions | Cystinuria MedDRA version: 20.0 Level: PT Classification code 10011778 Term: Cystinuria System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal… |
| Interventions | Product Name: ADV7103 Pharmaceutical Form: Prolonged-release granules INN or Proposed INN: potassium citrate monohydrate CAS Number: 6100-05-5 Current Sponsor code: ADV7103-CK Other descriptive name: potassium citrate Concentration unit: %… |
| Registration date | Sep 10, 2018 |
| Target size | 97 |
| Secondary IDs | B14CS;NCT04137978;2017-002068-42-FR |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: