Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets (NCT05637541) | Clinical Trial Compass
CompletedPhase 2
Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets
China90 participantsStarted 2023-01-03
Plain-language summary
A Randomized, Double-blind, Placebo-controlled and Multicenter Phase â…ˇ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
âś“. Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
âś“. Ability to complete research in accordance with test plan requirements;
âś“. Subjects (including partners) are willing to take effective pregnancy avoidance measures within 28 days after screening to the last study drug administration;
âś“. Male and female subjects aged between 18 and 70 years old (both inclusive);
âś“. The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), and the body mass index is within the range of 18-35 kg / m2 (including the critical value);
âś“. Have been taking a nucleoside analogue (entecavir \[ETV\], tenofovir dipiroxide fumarate \[TDF\], or profotenofovir \[TAF\]) for 1 to 3 years, were receiving treatment at the time of screening and agreed to receive the treatment offered in this study during the study;
âś“. Serum HBV DNA could be detected by high-sensitivity PCR with a dose of 20 IU/ ml \< HBV DNA \< 2000 IU/mL;
✓. Screening, ALT ≤ 5 x ULN and liver stiffness testing (LSM) meet the following requirements: ALT≤ 2 x ULN, LSM≤10.6 kPa; Or 2 x ULN≤ ALT≤ 5×ULN ，LSM\< 12.4 kPa.
Exclusion criteria
âś•. Patients with a history of allergy or suspected allergy to the active ingredient or excipients of the drug under study;
. Concomitant use of an inhibitor, inducer, or substrate of the cytochrome P450 enzyme 3A4 isoenzyme (CYP3A4) within 28 days before screening；
âś•. Patients with systemic use of immunosuppressants, immunomodulators (excluding interferon) and cytotoxic drugs within 6 months before screening; Or those who received live attenuated vaccine within 1 month before screening;
âś•. Acute infection requiring treatment with intravenous antibiotics within 2 weeks before screening or current infection requiring antiinfective treatment;
âś•. Patients with clinically significant acute or chronic liver disease caused by non-HBV infection who were judged by the investigator to be unsuitable for the study;
âś•. A history of cirrhosis (e.g., the subject had a histopathological examination of the liver and reported cirrhosis, or had an endoscopic examination indicating varicose esophagus and fundus veins); Or currently confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, hemorrhage of esophageal and fundus varices, spleen enlargement, ascites, etc.; Or there is evidence of progressive hepatic fibrosis;
✕. Primary liver cancer; Serum AFP (AFP) is greater than 50 ㎍ / L (or 50 ng/mL) or imaging suggest possible malignant liver placeholder; Patients with other malignant tumors or a history of other malignant tumors within 5 years before screening (except cured basal cell or squamous cell carcinoma of the skin and cervical carcinoma in situ);
✕. The presence of impaired gastrointestinal function or gastrointestinal disease that may affect oral drug absorption, such as severe gastrointestinal disease (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, and screening. Grade 2 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea)；