ISRCTN12811193
Completed
未知
HBsAg clearance in chronic hepatitis B patients with add-on pegylated interferon alpha 2a to ongoing tenofovir treatment: an open-label randomized controlled study
King Faisal Specialist Hospital and Research Centre0 sites50 target enrollmentAugust 26, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- King Faisal Specialist Hospital and Research Centre
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients above 18 years of age
- •2\. Chronic HBV patients receiving Tenofovir 300 mg orally daily for a minimum of 6 months
- •3\. HBeAg\-positive or HBeAg\-negative patients
- •4\. HBV DNA \<2000 IU/ml before recruitment
- •5\. HBsAg should be positive, and HBsAg titer should be measurable from the serum
Exclusion Criteria
- •1\. Side effects to medications or previous intolerance to Tenofovir or Peg IFN
- •2\. Impaired renal function with a GFR \<50
- •3\. Hemoglobin \<12 gm/L in women and \<13 gm/L in men
- •4\. Severe thrombocytopenia: platelets \<75000
- •5\. Neutropenia absolute neutrophil count (ANC)\< 1000
- •6\. Combined infection with HCV, HIV, HDV
- •7\. Drug\-induced, alcohol related or autoimmune liver disease
- •8\. Patients with severe depression or other significant psychiatric illness
- •9\. Previous history of lactic acidosis
- •10\. Advanced cardiac, pulmonary, renal or neurological diseases
Outcomes
Primary Outcomes
Not specified
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