A study conduct in several centres, further to a previous study, to evaluate the safety, tolerability and efficacy of ADV7103 at long term in the treatment of distal renal tubular acidosis
Phase 1
- Conditions
- Distal renal tubular acidosisMedDRA version: 20.1 Level: PT Classification code 10038535 Term: Renal tubular acidosis System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2013-003828-36-SK
- Lead Sponsor
- Advicenne Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Subject who has participated to and completed the previous Advicenne clinical Study B21CS.
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Subject who has not participated to Advicenne clinical Study B21CS
Subject for whom any safety issue could contraindicate her/his participation to the extension study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method