Chronic Hepatitis D Infection
Conditions
Keywords
chronic hepatitis D, hepalatide, hepatitis D virus
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.
Interventions
DRUGHepalatide
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.
DRUGHepalatide 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.
Sponsors
Shanghai HEP Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis D Virus(HDV) RNA level | Week 4 | HDV RNA level at week4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China, Mongolia
Outcome results
None listed