Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofo… (NCT03180619) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
United States, Canada124 participantsStarted 2017-06-29
Plain-language summary
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
All Participants (Parts A and B):
* Adult male or non-pregnant female individuals
* Documented evidence of chronic HBV infection
* Alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)
Part A Only (renal impairment):
* Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV deoxyribonucleic acid \[DNA\] \< lower limit of quantitation \[LLOQ\]) for ≥ 6 months prior to screening
* All individuals must have HBV DNA \< 20 International units per milliliter (IU/mL) at screening by central laboratory
* Both Hepatitis B e-Antigen (HBeAg) positive and negative individuals are eligible to participate
* Moderate renal impairment (30 milliliters per minute \[mL/min\] ≤ estimated glomerular filtration rate by the cockcroft-gault formula \[eGFRcg\] ≤ 59 mL/min), severe renal impairment (15 mL/min ≤ eGFRcg \< 30 mL/min) or end stage renal disease (ESRD) (eGFR \< 15 mL/min) maintained on hemodialysis (HD)
* Stable renal function (for participants with moderate or severe impairment): serum creatinine measured at least once within three months prior to screening. The measurement difference between the value measured within three months prior to screening versus the screening value must be ≤ 25% of the screening value
Part B Only (hepatic impairment):
* Maintained on TDF and/or other OAV(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA \< LLOQ) for ≥ 6 months prior to screen…
What they're measuring
1
Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24
Timeframe: Week 24
2
Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24
Timeframe: Week 24
3
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24