A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

NCT ID: NCT05244057

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2024-06-24

Brief Summary

The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years， which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up.

Detailed Description

Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. The aim of this study is to assess efficacy of a finitie treantment , that combination regimen of hepalatide+half dose Pegylated interferon + TAF , as measured by the primary efficacy endpoint. This study will be conducted in 3 periods: Screening Period (4weeks), Treatment Period (48 weeks) and Follow-up (FU) Period (8 weeks). Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, ophthalmologic examinations and physical examinations. Total duration of individual participation will be up to 60 weeks (including screening period).

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Hepalatide + TAF + PEG-IFN

Patients will receive 6.3mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

Group Type: EXPERIMENTAL

Hepalatide

Intervention Type: DRUG

6.3mg, s.c., qd for 48 weeks

Tenofovir Alafenamide Tablets

Intervention Type: DRUG

25mg, p.o., qd for 48 weeks

Pegylated Interferon alfa 2a

Intervention Type: DRUG

90ug, s.c., qw for 48 weeks

Placebo+ TAF + PEG-IFN

Patients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo of Hepalatide

Intervention Type: DRUG

s.c., qd for 48 weeks

Tenofovir Alafenamide Tablets

Intervention Type: DRUG

25mg, p.o., qd for 48 weeks

Pegylated Interferon alfa 2a

Intervention Type: DRUG

90ug, s.c., qw for 48 weeks

Interventions

Hepalatide

6.3mg, s.c., qd for 48 weeks

Intervention Type: DRUG

Placebo of Hepalatide

s.c., qd for 48 weeks

Intervention Type: DRUG

Tenofovir Alafenamide Tablets

25mg, p.o., qd for 48 weeks

Intervention Type: DRUG

Pegylated Interferon alfa 2a

90ug, s.c., qw for 48 weeks

Intervention Type: DRUG

Other Intervention Names

L47; Placebo; Vemlidy; Pegasys

Eligibility Criteria

Inclusion Criteria

• 1. HBsAg or/and HBV DNA Positive for at least 6 months

2. HBeAg negative

3. Received NAs stabilization therapy for at least 2 years

4. ALT≤ 2×ULN

5. HBV DNA< LLQD(lower limit of quantitative detection) in Screening

6. Serum total bilirubin<2×ULN

7. no childbirth plan within 2 years and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose, and that the woman is not pregnant or breastfeeding.

8. have not participant in another clinical trial within 3 months before screening

9. Subjects have good compliance with the protocol

10. Subjects understood and agreed to sign the informed consent form.

Exclusion Criteria

• 1. Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc

2. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinical diagnosis of cirrhosis by the investigator.

3. Decompensated liver disease

4. Child-Pugh score of B-C or over 6 points.

5. Subjects with any of the following circumstances

• History of decompensated liver disease
• History of serious heart disease (including unstable or uncontrolled heart disease within 6 months)
• Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatric disorders
• with history of organ transplantation
• with poorly controlled diabetes and hypertension
• with autoimmune diseases, immune-related extrahepatic manifestations, thyroid disease, malignant tumors, or in immunosuppressive therapy
• underlying diseases such as malignant tumor, severe infection, heart failure and chronic obstructive pulmonary disease and other serious diseases.
• with history of alcohol or drug abuse

6. Creatinine clearance <60 mL/min.

7. HAV, HCV, HDV, HEV or HIV co-infection

8. Subjects who must be treated with Nucleosides (acids) other than TAF during treatment period

9. Subjects who used interferon in the 6 months prior to the screening period

10. Positive for anti-HBV Pre-S1 antibody.

11. Hemocytopenia: White blood cells < 3 × 10^9 / L, neutrophil < 1.5 × 10^9 / L, platelet < 60 × 10^9 / L,

12. Female subjects pregnancy test positive

13. known to be allergic to the investigational drug or the underlying treatment drug

14. Other laboratories or auxiliary examinations are obviously abnormal

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tong Ren Hospital

OTHER

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Shanghai HEP Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qin Zhang

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tong Ren Hospital

Locations

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

L47-HB-FIN-1(New Finite)

Identifier Type: -

Identifier Source: org_study_id