Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection (NCT03903796) | Clinical Trial Compass
CompletedPhase 3
Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection
China963 participantsStarted 2018-08-16
Plain-language summary
The primary objective of this study is to compare the safety and efficacy of HS-10234 versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with chronic hepatitis B virus (HBV) infection.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening.
✓. Male and non-pregnant, non-lactating females, from 18 up to 65 years of age (based on the date of the screening visit). A negative serum pregnancy test at screening is required for female subjects of childbearing potential.
✓. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
✓. HBeAg-positive or HBeAg-negative chronic hepatitis B with all of the following: HBV DNA ≥ 2 x 104 IU/mL; Screening serum 1 ULN \< ALT level ≤ 10 ULN.
✓. Treatment-naive subjects (defined as \< 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced subjects (defined as subjects meeting all entry criteria \[including HBV DNA and serum ALT criteria\] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue) will be eligible for enrollment. Treatment-experienced subjects receiving oral antiviral treatment at Screening must continue their treatment regimen until the time of randomization, when it will be discontinued.
✓. Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit.
✓. Estimated creatinine clearance (CLcr) ≥ 50 mL/min（using the Cockcroft-Gault method）based on serum creatinine and actual body weight as measured at the screening evaluation, as follows:
Exclusion criteria
✕. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
What they're measuring
1
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
✕. Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
✕. Co-infection with HCV virus, HIV, or HDV.
✕. Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
✕. Any history of, or current evidence of, clinical hepatic decompensation (e.g. ascites encephalopathy or variceal hemorrhage).
✕. Abnormal hematological and biochemical parameters, including:
✕. Received solid organ or bone marrow transplant.
✕. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.