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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01925820
Eligibility Criteria:
Inclusion Criteria:
1. Adult male or female, 20 to 70 years of age Patient must have documented positive serum HBsAg for a minimum of 6 months prior to entry into study. Patients must show evidence of HBV replication and hepatitis documented by
* Positive serum HBV DNA within 3 months prior to entry (HBV DNA \>10,000 copies/mL or 2000 IU/mL).
* Negative serum HBeAg within 3 months prior to entry.
* Documented presence of abnormal alanine aminotransferase (ALT) twice within 6 months prior to entry, at least 3 months apart (2 to 10 folds above the upper normal level).
* Naïve to interferon, lamivudine, and telbivudine; but patients ever receiving adefovir, tenofovir or entecavir could be enrolled, only if they have been discontinued for more than 3 months.
2. Compensated liver disease with the following minimum hematological and serum biochemical criteria:
* Hemoglobin values of 12 gm/dL for both genders
* WBC 3,000/mm3
* Neutrophil count 1,500/ mm3
* Platelets 100,000/ mm3
* PT prolong 3 sec, INR 1.2
* Total bilirubin 2 mg/dL
* Albumin \> 3.5 g/dL
* Uric acid within normal ranges
* Serum creatinine 123.76 mmol/L ( 1.4 mg/dL)
* Hemoglobin A1C 8.5% for diabetic patients (whether on medication and/or controlled with diet)
3. Thyroid stimulating hormone (TSH), within normal ranges (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other.inclusion/exclusion criteria are met)
4. Negative serum antibody to hepatitis C (anti-HCV) and hepatitis D (anti-HDV)
5. Negative antibody to human immunodeficiency virus (anti-HIV)
6. Alfa-fetoprotein within normal range (obtained within the previous year, or if elevated and \<100 ng/ml, then a negative ultrasound for hepatocellular carcinoma within prior 3 months is required.)
7. Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules \*Patients with well compensated liver cirrhosis (Child-Pugh A), in the absence of splenomegaly (by abdominal ultrasonography) and varices (if patients ever received upper GI endoscope),could be enrolled.
Exclusion Criteria:
1. Women who are pregnant or nursing.
2. Prior treatment for hepatitis with any interferon, lamivudine, telbivudine, or other investigational agents.
3. Prior treatment for hepatitis with immunomodulatory drug within previous 2 years.
4. Suspected hypersensitivity to interferon.
5. Have evidence of cirrhosis with the presence of splenomegaly or varices, or evidence of decompensated cirrhosis.
6. History of severe psychiatric disease, especially depression.
7. Concurrent malignancies (including hepatocellular carcinoma).
8. Unstable or significant cardiovascular diseases (e.g., angina, congestive heart failure,recent myocardial infarction, severe hypertension or significant arrhythmia; subjects with ECG showing clinically significant abnormalities).
9. Prolonged exposure to known hepatotoxins such as alcohol or drugs
10. History of thyroid disease poorly controlled on prescribed medication
11. Poorly controlled diabetes mellitus
12. Have suspected or confirmed significant hepatic disease from an etiology other than HBV (e.g., alcohol, autoimmune disease etc.)
13. Patients co-infected with hepatitis C, hepatitis D and /or HIV
14. Severe renal disease or myeloid dysfunction
15. History of organ transplantation other than cornea and hair transplant
16. Any medical condition requiring, or likely to require during the course of the study,chronic systemic administration of steroids
17. Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01925820
Study Brief:
Protocol Section:
NCT01925820