Clinical trial NCT05827146: Study of Hepalatide in Chronic Hepatitis D(CHD) Patients
Official title: Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis D Infection
Keywords: chronic hepatitis D
hepalatide
hepatitis D virus
Lead sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hepatitis D Virus(HDV) RNA level
timeFrame: Week 4
Secondary outcomes:
measure: Change in Alanine transaminase(ALT) from baseline
timeFrame: Week 4
measure: Change in HDV RNA from baseline
timeFrame: Week 4
Other outcomes:
measure: ALT level
timeFrame: Week 4
measure: Number of Participants With ALT normalization
timeFrame: Week 4
Locations:
city: Urumqi
country: China
facility: The first affiliated hospital of Xinjiang Medical University
state: Xinjiang
city: Changchun
country: China
facility: The first hospital of Jilin University
city: Ulaanbaatar
country: Mongolia
facility: the National cancer center of Mongolia
Study officials:
affiliation: The First Hospital of Jilin University
name: Junqi Niu
role: PRINCIPAL_INVESTIGATOR
References: