Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

Sponsor

Shanghai HEP Pharmaceutical Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05827146

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis D Infection	Drug: Hepalatide Drug: Hepalatide Placebo	Phase 2

Detailed Description

This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter Phase IIa clinical trial. The CHD subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Subjects will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hepalatide 2.1mg 2.1 mg/day subcutaneously (s.c.) for 4 week	Drug: Hepalatide Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily. Other Names: L47
Experimental: Hepalatide 4.2mg 4.2 mg/day subcutaneously (s.c.) for 4 week	Drug: Hepalatide Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily. Other Names: L47
Experimental: Hepalatide 6.3mg 6.3 mg/day subcutaneously (s.c.) for 4 week	Drug: Hepalatide Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily. Other Names: L47
Placebo Comparator: Placebo 2.1mg/4.2mg/6.3mg Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week	Drug: Hepalatide Placebo Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily. Other Names: Placebo

Outcome Measures

Primary Outcome Measures

Hepatitis D Virus(HDV) RNA level [Week 4]
HDV RNA level at week4

Secondary Outcome Measures

Change in Alanine transaminase(ALT) from baseline [Week 4]
Changes in ALT values at Week 4 compared to baseline
Change in HDV RNA from baseline [Week 4]
Changes in HDV RNA levels at Week 4 compared to baseline

Other Outcome Measures

ALT level [Week 4]
ALT level at Week 4
Number of Participants With ALT normalization [Week 4]
Number of Participants With Normal ALT at Week 4

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female, 18-65 years old (both inclusive);
HBsAg (+) and/or HBV DNA (+) for at least 6 months (clinically diagnosed as "chronic hepatitis B");
HDV-antibody (IgG/IgM) (+) and HDV RNA (+);
1×ULN <ALT<10×ULN；
Patients with hepatitis B eligible to receive treatment with NAs according to current guidelines for the diagnosis and treatment of hepatitis B;
Patients who do not plan a pregnancy within two years (women who are not pregnant or lactating) and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose;
Patients who did not participate in any other clinical trials within 3 months;
Patients with good compliance with the study protocol;
Patients who understand and agree to sign an informed consent form.

Exclusion Criteria:

Decompensated liver disease: Direct bilirubin > 1.2× ULN, prothrombin time > 1.2× ULN, and serum albumin < 35 g/L;
Patients with abnormal results of routine hematology test: White blood cell count (WBC) < 3×109/L, neutrophil count < 1.5×109/L and platelet count < 60×109/L;
Severe liver fibrosis or cirrhosis: Definitely diagnosed liver cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed liver cirrhosis by the investigator, or a Metavir fibrosis score of 4 on a liver biopsy sample, or a Child-Pugh score > 7 for liver function assessment;
Patients who have any of the following conditions:

A history of decompensated liver disease (ascites, jaundice, hepatic encephalopathy, variceal bleeding);
A history of serious cardiovascular disease (including unstable or uncontrolled cardiovascular disease within 6 months);
Serious mental illness or a history of serious mental illness;
A history of organ transplantation;
Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or hypertension;
Autoimmune disease, immune-related extrahepatic manifestations (vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumor, and receiving immunosuppressive therapy;
Underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, and other severe diseases;
A history of alcohol or drug abuse.

Creatinine clearance < 60 mL/min;
HAV/HCV/HEV/HIV co-infection;
Resistance to or poor response to Entecavir;
An allergic reaction to Entecavir;
Patients who have used interferon within 3 months before the screening period;
Previously received L47 or Bulevirtide;
Women who have a positive pregnancy test;
Patients who have other significantly abnormal results of laboratory or auxiliary tests and are unsuitable for this trial.