Chronic hepatitis B
Conditions
Interventions
Trade Name: Viread
Product Name: viread
Product Code: EMEA/H/C/000419
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TENOFOVIR
CAS Number: 147127-20-6
Current Sponsor code: TDF1
Concen
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: all adult, cHBV-infected patients on tenofovir or entecavir or without treatment are eligable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: HIV-infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess incidence of, clinical determinants for, dose reduction in and reversibility of tenofovir associated KPTD in HBV-monoinfected patients. ;Secondary Objective: Secondary objectives are to assess kidney tubular function in patients with cHBV on entecavir and without treatment, to relate plasma and intracellular levels of tenofovir (diphosphate) to the occurrence of KPTD and to report on plasma and intracellular levels of tenofovir (diphosphate) in cHBV. ;Primary end point(s): 1. The prevalence and incidence of renal insufficiency and kidney proximal tubular dysfunction (KPTD) in chronic hepatitis B patients on tenofovir, entecavir or without treatment. KPTD is defined as the presence of at least two of the following; a decreased renal threshold phosphate concentration (TmP/GFR 25% decrease in renal clearance since initiation of TDF. 2. Reversibility of renal insufficiency and KPTD following dose reduction at 24 weeks. Reversibility is defined as GFR within 10% of baseline GFR/no agreement with KPTD criteria ;Timepoint(s) of evaluation of this end point: 1. week 48 2. week 24 after dose reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The values of plasma TFV, urine TFV and intracellular TFV-DP levels in studygroup 1 on normal TDF dose and in those on reduced TDF dose. 2. The relation between plasma TFV, urine TFV and intracellular TFV-DP levels and the occurrence of KPTD in studygroup 1. 3. The percentage of patients in studygroup 1, meeting the criteria for dose reduction, maintaining adequate viral suppression.;Timepoint(s) of evaluation of this end point: 1 and 2: At week 4, 12, 24, 36, 48 and after tenofovir dose reduction at week 4, 12, 24, 36, 48. 3: At week 4, 8, 12, 24, 36 and 48 after dose reduction. | — |
Countries
Netherlands
Contacts
Public ContactClinical Research Bureau MDL
Erasmus MC
Outcome results
None listed