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 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
NCT ID:
NCT02604212
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 to 75 years of age.
* Written informed consent.
* No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment.
* No new abnormal finding of clinical relevance at the screening evaluation.
* Diagnosis of HBeAg positive, immune active, chronic HBV infection.
* \> 2months of continuous treatment with daily, oral entecavir or tenofovir.
* Willingness to continue taking entecavir or tenofovir throughout the study.
* Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners).
Exclusion Criteria:
* Pregnant or lactating
* Acute signs of hepatitis/other infection within 4 weeks of screening.
* Antiviral therapy other than entecavir or tenofovir within 3 months of screening.
* Prior treatment with interferon in the last 3 years.
* Use within the last 6 months or anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
* Use of prescription medication within 14 days prior to treatment administration except: topical products without systemic absorption, statins (except rosuvastatin), hypertension medications, or hormonal contraceptives.
* Depot injection or implant of any drug within 3 months prior to treatment administration, except injectable/implantable birth control.
* Diagnosis of diabetes mellitus.
* History of autoimmune disease especially autoimmune hepatitis.
* Human immunodeficiency virus (HIV) infection.
* Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis.
* Hypertension defined as blood pressure \> 150/100 mmHg.
* History of cardiac rhythm disturbances.
* Family history or 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, or in situ cervical cancer.
* Has had a major surgery within 3 months of screening.
* History of alcohol and/or drug abuse \< 12 months from screening.
* Regular uses of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week).
* Evidence of severe systemic acute inflammation, sepsis, or hemolysis.
* Diagnosed with a significant psychiatric disorder.
* Use of recreational drugs, such as marijuana, within 3 months prior to screening.
* Use of drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to screening.
* History of allergy to bee sting.
* Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.
* Clinically significant history or presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease.
* Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction.
* Clinically significant history or presence of poorly controlled/uncontrolled systemic disease.
* History of fever within 2 weeks of screening.
* Immunized with a live attenuated vaccine within 7 days prior to dosing or planned vaccination (excluding flu vaccine by injection).
* Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk.
* Participated in excessive exercise/physical activity within 7 days of screening or planned during the trial.
* 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:
NCT02604212
Study Brief:
Protocol Section:
NCT02604212