HBsAg clearance with pegylated interferon and tenofovir combinatio

Not Applicable

Completed

• Conditions: Chronic hepatitis B; Infections and Infestations

• Registration Number: ISRCTN12811193
• Lead Sponsor: King Faisal Specialist Hospital and Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-26
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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
11. Liver cirrhosis with Child score (CTP) seven and above
12. Decompensated cirrhosis
13. Pregnancy and lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified