Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

NCT05827146 | Completed Phase 2

• 1 other identifier: L47-HD-IIa
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Chronic Hepatitis D Infection

Keywords

chronic hepatitis D; hepalatide; hepatitis D virus

Outcome Measures

Primary Outcomes (1)

• Hepatitis D Virus(HDV) RNA level

  HDV RNA level at week4

  Week 4

Secondary Outcomes (2)

• Change in Alanine transaminase(ALT) from baseline

  Week 4

• Change in HDV RNA from baseline

  Week 4

Other Outcomes (2)

• ALT level

  Week 4

• Number of Participants With ALT normalization

  Week 4

Study Arms (4)

Hepalatide 2.1mg

EXPERIMENTAL

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

Drug: Hepalatide

Hepalatide 4.2mg

EXPERIMENTAL

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

Drug: Hepalatide

Hepalatide 6.3mg

EXPERIMENTAL

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

Drug: Hepalatide

Placebo 2.1mg/4.2mg/6.3mg

PLACEBO COMPARATOR

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

Drug: Hepalatide Placebo

Interventions

Hepalatide 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.

Also known as: L47

Hepalatide 2.1mg; Hepalatide 4.2mg; Hepalatide 6.3mg

Hepalatide Placebo 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.

Also known as: Placebo

Placebo 2.1mg/4.2mg/6.3mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (+);
• ×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.

You may not qualify if:

• 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:
• 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;

Sponsors & Collaborators

• Shanghai HEP Pharmaceutical Co., Ltd.: lead

Study Sites (3)

The first affiliated hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

The first hospital of Jilin University

Changchun, China

Location

the National cancer center of Mongolia

Ulaanbaatar, Mongolia

Location

MeSH Terms

Conditions

Hepatitis D, Chronic

Condition Hierarchy (Ancestors)

Hepatitis D; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junqi Niu

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: April 24, 2023
• Study Start: October 7, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2); MO (1)