Last updated: April 22, 2024
Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
Overall Status: Completed
Phase
2
Condition
Hepatitis
Liver Disorders
Treatment
Hepalatide
Hepalatide Placebo
Clinical Study ID
NCT05827146
L47-HD-IIa
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, 18-65 years old (both inclusive);
- HBsAg (+) and/or HBV DNA (+) for at least 6 months (clinically diagnosed as "chronichepatitis 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 currentguidelines for the diagnosis and treatment of hepatitis B;
- Patients who do not plan a pregnancy within two years (women who are not pregnant orlactating) and agree to take effective contraceptive measures throughout the treatmentperiod 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
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: Definitelydiagnosed decompensated cirrhosis by imaging examinations such as a Color Dopplerultrasound and CT of the abdomen or clinically diagnosed decompensated cirrhosis bythe investigator, or a Metavir fibrosis score of 4 on a liver biopsy sample, or aChild-Pugh score > 7 for liver function assessment;
- Patients who have any of the following conditions:
- A history of decompensated liver disease (ascites, jaundice, hepaticencephalopathy, variceal bleeding);
- A history of serious cardiovascular disease (including unstable or uncontrolledcardiovascular 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 orhypertension;
- 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 obstructivepulmonary 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 auxiliarytests and are unsuitable for this trial.
Study Design
Total Participants: 23
Treatment Group(s): 2
Primary Treatment: Hepalatide
Phase: 2
Study Start date:
October 07, 2023
Estimated Completion Date:
February 01, 2024
Study Description
Connect with a study center
The first affiliated hospital of Xinjiang Medical University
Urumqi, Xinjiang
ChinaSite Not Available
The first hospital of Jilin University
Changchun,
ChinaSite Not Available
the National cancer center of Mongolia
Ulaanbaatar,
MongoliaSite Not Available
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