Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT06649266
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to give written informed consent for participation in the trial.
2. Male or female participant aged 18 to 65 years, inclusive.
3. Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at the time of the screening visit.
4. Documented evidence of HDV infection in medical history, i.e., HDV antibodies (HDVAb) and/or HDV RNA positive test results within at least 6 months prior to screening.
5. Documented evidence of HBV infection in medical history, i.e., HBsAg and/or HBV DNA positive test results within at least 6 months prior to screening.
6. Documented absence of liver cirrhosis, defined as an LSM ≥ 10 kPa measured on FibroScan® elastography at screening.
Exclusion Criteria:
1. Laboratory results at screening as follows, or any clinically significant laboratory parameter outliers that may interfere with the evaluation of efficacy and/or safety in the trial, at the discretion of the Investigator:
* α-fetoprotein (AFP) \> 50 µg/L.
* Albumin concentration \< 3.0 g/dL.
* International normalized ratio (INR) \> 1.5.
* Platelet count \< 90 × 109/L.
* Direct bilirubin \> 2 × ULN, Gilbert syndrome excluded.
* Creatinine concentration \> 1.5 × ULN.
* Creatinine clearance \< 60 mL/min, according to the Cockcroft-Gault equation.
2. Positive result at screening for hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV) and/or prior diagnosis of syphilis, acute hepatitis A and/or acute hepatitis E.
3. Prior diagnosis of other liver diseases of non-HBV or non-HDV aetiology, including autoimmune liver disease (e.g., autoimmune hepatitis, primary biliary cholangitis or primary sclerosing cholangitis), inherited metabolic liver disease (e.g., haemochromatosis, Wilson's disease, familial intrahepatic cholestasis), drug-induced liver disease and/or non alcoholic steatohepatitis (NASH) assessed as moderate or above, at the discretion of the Investigator.
4. Prior or current diagnosis of liver cirrhosis.
5. History of or active hepatic decompensation, e.g., ascites, variceal bleeding or hepatic encephalopathy, at the discretion of the Investigator.
6. History of organ transplantation, previous or concurrent HCC or imaging finding suggesting malignant liver lesions, at the discretion of the Investigator.
7. Signs of liver malignancy in abdominal ultrasound at screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06649266
Study Brief:
Protocol Section:
NCT06649266