Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

NCT ID: NCT05827146

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-07
• Study Completion Date: 2024-02-01

Brief Summary

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

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.

Conditions

Chronic Hepatitis D Infection

Study Design

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

Study Groups

Hepalatide 2.1mg

2.1 mg/day subcutaneously (s.c.) for 4 week

Group Type: EXPERIMENTAL

Hepalatide

Intervention Type: DRUG

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.

Hepalatide 4.2mg

4.2 mg/day subcutaneously (s.c.) for 4 week

Group Type: EXPERIMENTAL

Hepalatide

Intervention Type: DRUG

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.

Hepalatide 6.3mg

6.3 mg/day subcutaneously (s.c.) for 4 week

Group Type: EXPERIMENTAL

Hepalatide

Intervention Type: DRUG

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.

Placebo 2.1mg/4.2mg/6.3mg

Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week

Group Type: PLACEBO_COMPARATOR

Hepalatide Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

L47; Placebo

Eligibility Criteria

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;
• Severely decompensated hepatic fiborosis or decompensated cirrhosis: Definitely diagnosed decompensated cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed decompensated 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:

1. A history of decompensated liver disease (ascites, jaundice, hepatic encephalopathy, variceal bleeding);

2. A history of serious cardiovascular disease (including unstable or uncontrolled cardiovascular disease within 6 months);

3. Serious mental illness or a history of serious mental illness;

4. A history of organ transplantation;

5. Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or hypertension;

6. Autoimmune disease, immune-related extrahepatic manifestations (vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumor, and receiving immunosuppressive therapy;

7. Underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, and other severe diseases;

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai HEP Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junqi Niu

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

The first affiliated hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The first hospital of Jilin University

Changchun, , China

the National cancer center of Mongolia

Ulaanbaatar, , Mongolia

Countries

China; Mongolia

Other Identifiers

L47-HD-IIa

Identifier Type: -

Identifier Source: org_study_id