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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT00114361
Eligibility Criteria:
Inclusion Criteria:
* Chronic hepatitis B
* Biopsy performed within one year prior to screening or during screening
* ALT \> 1.5 x ULN
* HBeAg negative, anti-HBeAg positive
* HBV DNA \> 10E5 copies/ml
* Age 18-70 years
* Written informed consent
* Hepatic imaging without evidence of HCC
* All fertile males and females must be using two forms of effective contraception
Exclusion Criteria:
* Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol
* Severe hepatitis activity as documented by ALT \> 10 x ULN
* Advanced liver disease
* Pre-existent leucopenia or thrombopenia
* Co-infection with HCV,HDV or HIV
* Other acquired or inherited causes of liver disease
* Alpha fetoprotein \> 50 ng/ml.
* Evidence of severe renal disease
* Hyper- or hypothyroidism
* Significant cardiovascular or pulmonary dysfunction, malignancy,immunodeficiency syndromes
* Immune suppressive treatment within the previous 6 months
* Contra-indications for alpha-interferon therapy
* Pregnancy, breast-feeding
* Any medical condition requiring chronic systemic administration of steroids
* Substance alcohol or drug abuse
* Subjects with clinically significant retinal abnormalities
* Subjects with clinically significant hearing abnormalities
* Hemoglobinopathies
* Subjects with known hypersensitivity to ribavirin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00114361
Study Brief:
Protocol Section:
NCT00114361