Trials / Unknown
UnknownNCT02267473
Hepatitis B Patients Under Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function
A Multicenter, Prospective, Observational Study of Patients With Chronic Hepatitis B Under Various Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- Johann Wolfgang Goethe University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
Summary
Patients with chronic Hepatitis B who are under oral antiviral treatment for at least 6 months at study start will be monitored once yearly for kidney function changes within their routine outpatient visit. Therefore urine samples will be collected and some additional blood test will be done within the routine blood sampling.
Detailed description
This non-interventional, long-term observational cohort study will evaluate demographic, clinical, biochemical and virological parameters of outpatients with chronic Hepatitis B who are under oral antiviral treatment with an approved Nucleos(t)ide for \> 6 months at study inclusion. During their routine outpatient visits annually an assessment of their kidney function especially for a proximal tubular dysfunction will be performed and their comedication will be explored. Patients included in the study are followed up for 5 years.
Conditions
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2020-10-01
- Completion
- 2020-12-01
- First posted
- 2014-10-17
- Last updated
- 2018-04-02
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02267473. Inclusion in this directory is not an endorsement.