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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT05195450
Eligibility Criteria:
Inclusion Criteria:
\- HBsAg+
* Persistent normal ALT 3-6m apart (\<30 IU/ml in male and \<20 IU/ml in female)
* HBV DNA \< 2000 IU/ml
* LSM \<8 Kpa
Exclusion Criteria:
* Prior NUC/IFN exposure
* Renal dysfunction (Serum Creatinine \>1.5 mg/dl)
* Known liver cirrhosis/ esophageal varices
* Any clinical decompensation (CD)
* Pre-existing hepatocellular carcinoma
* Pregnancy
* Healthcare workers (HCW)
* Post transplant, patients with advance malignancy or on chemotherapy
* Co-infections - Hepatitis C, Hepatitis D, Human immunodeficiency virus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05195450
Study Brief:
Protocol Section:
NCT05195450