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Comparison of viral control between two tenofovir dose reduction regimens (300 mg every 48 hours vs 300 mg every 72 hours) in chronic hepatitis B patients with moderate renal impairment from tenofovir induced renal dysfunction.

Comparison of viral control between two tenofovir dose reduction regimens (300 mg every 48 hours vs 300 mg every 72 hours) in chronic hepatitis B patients with moderate renal impairment from tenofovir induced renal dysfunction.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180207001
Enrollment
108
Registered
2018-02-07
Start date
2018-01-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal impairment HBV viral control tenofovir dose reduction chronic hepatitis B renal impairment

Interventions

Same as previous dose&#44
no further dose adjustment,TDF dose reduction from 300 mg q 48 hr to 300 mg q 72 hr
No Intervention Drug,Active Comparator Drug
TDF q 48 hr,TDF q 72 hr

Sponsors

Gastroenterological Association of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: chronic hepatitis B age equal or more than 18 years old received tenofovir at least 6 months before enrollent, current use of tenofovir mono therapy (dose at least 300 mg q 48 hr) eGFR 30-60 mL/min/1.73 m2 suppressible HBV viral load

Exclusion criteria

Exclusion criteria: known or reversible cause of renal impairment Fanconi syndrome HIV coinfection History of poor drug compliance Hepatocellular carcinoma

Design outcomes

Primary

MeasureTime frame
percentage of chronic hepatitis B patients who still viral load suppressed 3, 6, 9, 12 months HBV viral load—

Secondary

MeasureTime frame
change of glomerular and tubular function 3, 6, 9, 12 months eGFR, UPCR, TmP/GFR, urine NGAL—

Countries

Thailand

Contacts

Public ContactKarn Poosanasuwansri

Siriraj

karn.pooh8@gmail.com0867726680

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026