The effect of Combination Peg interferon –alpha to Tenofovir versus each one of the treatment modalities alone on Patients with HBeAg-negative: A randomized clinical trial
Phase 3
- Conditions
- Hepatitis B.Chronic viral hepatitis B without delta-agentB18.1
- Registration Number
- IRCT20181113041635N1
- Lead Sponsor
- vice presidency for siences and technology , Iran national silences foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients with the age of 18-65 years
Negative Hepatitis B e antigen at baseline
Quantifiable serum hepatitis B viral DNA load> 2000 IU/ml
At least six months from the initial diagnosis
Those with no history of receiving an antiviral drug
Exclusion Criteria
Hepatitis C, D and HIV Viruses co-infection
Dialysis patients with renal impairment
Severe liver diseases
History of previous hepatitis B treatment (for at least 30 days)
Other liver comorbidities such as Autoimmune Hepatitis Hepatocellular Carcinoma, uncompensated cirrhosis
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The final end-points were rate of HBV DNA loss<20 IU/ml at week 48. Timepoint: HBV DNA load Will be measured. in the Twelve, Twenty-four, thirty-six and 48 weeks for all patients. Method of measurement: by using of Cobas TaqMan polymerase chain reaction (Roche Diagnostics Basel, Switzerland) by Keyvan Virology Specialty Laboratory (KVSL).
- Secondary Outcome Measures
Name Time Method