Health Condition 1: null- Chronic hepatitis B virus (HBV) HBeAgâ??negative infection
Conditions
Interventions
Intervention1: Drug: Tenofovir alafenamide
Tenofovir alafenamide 25 mg tablet administered orally once daily
Drug: Tenofovir DF 300 mg tablet administered orally once daily
Other Name: Viread®
: Ap
Sponsors
Gilead Sciences Inc
KlinEra Corporation India
Eligibility
Inclusion criteria
Inclusion criteria: 1 Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2 Adult males and non-pregnant, non-lactating females, 18 years of age and older 3 Documented evidence of chronic HBV CHB infection 4 Hepatitis e antigen HBeAg negative, chronic hepatitis B with all of the following HBeAg-negative and hepatitis B e antibody HBeAb positive at screening Screening HBV DNA greater than or equal to 2 x 10 upon 4 IU per mL Screening serum alanine aminotransferase ALT level greater than 60 U/L males or greater than 38 U per L females and greater than 10 x the upper limit of the normal range ULN 5 Treatment-naive participants (defined as lower than 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, OR treatment-experienced participants defined as participants meeting all entry criteria including HBV DNA and serum ALT criteria and with greater than or equal 12 weeks of previous treatment with any nucleoside or nucleotide analogue 6 Previous treatment with interferon pegylated or non pegylated must have ended at least 6 months prior to the baseline visit. 7 Adequate renal function 8 Normal ECG
Exclusion criteria
Exclusion criteria: 1 Females who are breastfeeding 2 Males and females of reproductive potential who are unwilling to use an effective, protocol specified methods of contraception during the study 3 Co-infection with hepatitis C, HIV, or hepatitis D 4 Evidence of hepatocellular carcinoma 5 Any clinical and/or laboratory evidence of hepatic decompensation 6 Abnormal hematological and biochemical parameters, including aspartate aminotransferase AST greater than 10 x ULN 7 Received solid organ or bone marrow transplant 8 History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection participants under evaluation for possible malignancy are not eligible 9 Currently receiving therapy with immunomodulators eg corticosteroids investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion 10 Subjects receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or subjects with a known hypersensitivity to study drugs, metabolites, or formulation excipients 11 Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance 12 Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with hepatitis B virus (HBV) DNA less than 29 IU per mL The primary efficacy endpoint is determined by the achievement of HBV DNA less than 29 IU per mL at Week 48. The proportion of subjects with plasma HBV DNA 29 IU/mL at Weeks 96, 144, 240, and 384 The proportion of subjects with plasma HBV DNA 29 IU/mL(target not detected) at Weeks 48, 96, 144, 240, and 384 Timepoint: Week 48 Week 96 Week 144 Week 240 Week 384 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Percent change from baseline in hip and spine bone mineral density (BMD) at Week 48 â?¢ Change from baseline in serum creatinine at Week 48. .The proportion of subjects in each treatment arm with tolerability failure (defined as an adverse event [AE] leading to permanent discontinuation of study drug) at Weeks 48, and 96, 144, 240, and 384 will be summarized. Change from baseline in serum creatinine will be assessed at every visit and summarized through Week 384/ED.Timepoint: Week 24, 48, 72, 96, 120, and 144, and every 48 weeks until Week 384/ED. | — |
Countries
Australia, Canada, China, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactMr Sunil Verma
Klinera Corporation India
Outcome results
None listed