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Effect of Pegylated Interferon alfa-2a plus Adefovir in the treatment of chronic hepatitis B with genotype D

Phase 3
Conditions
Chronic hepatitis B.
Chronic viral hepatitis B without delta-agent
Registration Number
IRCT138711201155N4
Lead Sponsor
Guilan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
74
Inclusion Criteria

Presence of hepatitis B for more than 6 month, ALT more than 1/1 normal upper limit and less than 10 ULN, 1810.000 copies/ml.
Exclusion criteria: Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study, previous treatment, coinfection with Hepatitis A,C,D viruses or HIV, Severe dysfunction of liver and kidney, pregnancy, breast feeding, refusing to give informed consent .

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response to treatment. Timepoint: 24 week after treatment. Method of measurement: HBV-DNA<200copies/ml measure with PCR.;Response to treatment. Timepoint: 24 week after treatment. Method of measurement: normal level of ALT measure with Biochemical.
Secondary Outcome Measures
NameTimeMethod
Adverse effects. Timepoint: monthly. Method of measurement: Clinical evaluation and lab tests.
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