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:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT02452528
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 to 75 years of age
* Written informed consent
* Body mass index (BMI) between 17.5 and 30.0 kg/m2
* No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment
* No abnormal finding of clinical relevance
* Diagnosis of HBeAg positive, immune active, chronic HBV infection
* \> 2 months of continuous treatment with daily oral entecavir or tenofovir
* Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive)
Exclusion Criteria:
* Pregnant or lactating
* Acute signs of hepatitis/other infection within 4 weeks of screening
* Hepatic transaminases (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) \> 3 times the upper limits of normal
* Liver Elastography (i.e. FibroScan®) score \> 9
* Antiviral therapy other than entecavir or tenofovir within 3 months of screening
* Prior treatment with interferon in the last 3 years
* Use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants within 6 months of screening
* Use within 7 days prior to screening of dietary and/or herbal supplements that can interfere with liver metabolism
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days of study drug administration
* Use of prescription medication within 14 days prior to study drug administration
* Depot injection/implant of any drug except birth control within 3 months prior to study drug administration
* Known diagnosis of diabetes mellitus
* History of autoimmune disease
* Human immunodeficiency virus (HIV) infection
* Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis
* Hypertension; blood pressure \> 150/100 mmHg
* History of cardiac rhythm disturbances
* Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death
* Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease within 6 months prior to study entry
* History of malignancy, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, in situ cervical cancer
* Major surgery within 3 months of screening
* History of alcohol and/or drug abuse \< 12 months from screening
* Regular use of alcohol within 6 months (ie, more than 14 units of alcohol per week)
* Evidence of systemic acute inflammation, sepsis, or hemolysis
* Diagnosed with a significant psychiatric disorder
* Use of drugs of abuse
* History of allergy to bee venom
* Positive reaction to the bee venom allergy immunoglobulin E (IgE) test
* Use of investigational agents or devices within 30 days
* Clinically significant inherited or acquired gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease
* Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
* Clinically significant history or presence of uncontrolled systemic disease
* Donated or had a loss of whole blood of 50 milliliters (mL) to 499 mL within 30 days or more than 499 mL between 31 and 56 days prior to study treatment
* History of fever within 2 weeks of screening
* Immunization/planned immunization with live attenuated vaccine except influenza vaccine
* Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk
* Excessive exercise/physical activity within 7 days of screening/enrolment or during study
* History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02452528
Study Brief:
Protocol Section:
NCT02452528