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:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT04365933
Eligibility Criteria:
Inclusion Criteria:
* Has given voluntary written informed consent before performance of any study related procedure.
* Are treatment naive or without HBV treatment for at least 60 days or 5 times the elimination half-life, whichever is longer.
* Patient has CHB:
1. HBV DNA ≥ 20,000 IU/mL for HBeAg positive and ≥2'000 for HBeAg negative and
2. HBsAg ≥ 2.5 log10 IU/mL.
* Has liver imaging to screen for hepatocellular carcinoma or concomitant pancreaticobiliary disease either in the prior 6 months or at screening.
* Patient is not of childbearing potential or, if of childbearing potential, is not pregnant as confirmed by a negative serum human chorionic gonadotropin test at screening and is not planning a pregnancy during the course of the study.
Exclusion Criteria:
* Is an employee of a clinical research organization, vendor, or Sponsor involved with this study.
* Has known hepatocellular carcinoma or pancreaticobiliary disease.
* Neutropenia (defined by two confirmed values during Screening period of \< 1500/μL).
* Has Gilbert syndrome.
* Shows evidence of worsening liver tests, defined as either a confirmed (2 assessments at least 3 days apart) increase \> 2 ULN ALT or AST or an increase of \> 1.5 × baseline value of TBL or associated with clinical signs or symptoms of liver impairment.
* Has known or suspected non-CHB liver disease
* History of cirrhosis or liver decompensation, including ascites, hepatic encephalopathy, or presence of oesophageal varices.
* Probable or possible F4 stage with a vibration controlled transient elastography (VCTE) \> 11.7 kPa leads to exclusion
* Has known history of alcohol abuse or daily heavy alcohol consumption
* Has any of the following exclusionary laboratory results at screening:
1. ALT \> 2 × ULN, AST \> 2 × ULN
2. INR \> 1.2 × ULN, (normal range is 0.8 to 1.2)
3. Platelet count \< 100 G/L
4. Estimated glomerular filtration rate \< 50 mL/min/1.73m2 (the Modification of Diet in Renal Disease formula)
5. Thyroid-stimulating hormone \> 1.5 × ULN or abnormal free triiodothyronine or free thyroxine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04365933
Study Brief:
Protocol Section:
NCT04365933