Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Korábbi kezelés

• Malignant tumors were diagnosed within 5 years prior to randomization；
• Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
• History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
• Participated in clinical study of other drugs (received experimental drugs);

Más betegség

• History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
• With autoimmune disease;
• History of solid organ transplantation or hematopoietic stem cell transplantation;
• Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
• Allergic to a drug ingredient or component;

Laborértékek

• Laboratory tests during the screening period were obviously abnormal;

Egyéb

• Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
• Pregnant or nursing women;
• Other reasons for ineligibility as judged by the investigators.

• Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
• Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
• HBeAg negative at screening;
• On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
• Need to take effective contraceptive measures；
• Volunteer to sign an informed consent.