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NCT07917910
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Conditions: Chronic Hepatitis B Virus Infection
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Suzhou HepaThera Biotech Co., Ltd.
Summary
Phase II trial of HT-101 + HT-102 in CHB: (1) functional cure in treatment-naïve patients (vs placebo); (2) efficacy of sequential interferon in previously treated patients.
Eligibility Criteria
Inclusion Criteria:
1. Having a full understanding of the nature, significance, possible benefits, and risks of this study, demonstrating good compliance, and voluntarily signing the Informed Consent Form (ICF);
2. Treatment-naïve participants clinically diagnosed with chronic Hepatitis B virus (HBV) infection;
3. Male or female participants of childbearing potential (WOCBP) must commit to having no plans for procreation, sperm or ovum donation during the study and for 6 months after the last dose, and must voluntarily use a highly effective contraceptive method.
Exclusion Criteria:
1. Previous history of cirrhosis, or evidence suggesting significant hepatic fibrosis or cirrhosis;
2. History of hepatocellular carcinoma (HCC) or suspected HCC;
3. Individuals who have experienced major trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo major surgery during the study period;
4. Previous history of solid organ transplantation or hematopoietic stem cell transplantation (HSCT);
5. Pregnant or lactating women, or those with a positive pregnancy test;
6. Known allergy to any component of the investigational product and/or other products of the same class, or history of severe food or drug allergy, or allergic constitution;
7. Participants deemed by the investigator, for any other reason, to be unsuitable to participate in this study;
Source: ClinicalTrials.gov (NCT07917910). StuddyBuddy aggregates publicly available trial information.