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Comparison of Peginterferon Alfa-2a Versus Entecavir in Patients with HBeAg-Positive Chronic Hepatitis B With Mildly Elevated Alanine Aminotransferase Levels

Comparison of Peginterferon Alfa-2a Versus Entecavir in Patients with HBeAg-Positive Chronic Hepatitis B With Mildly Elevated Alanine Aminotransferase Levels

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000541
Enrollment
Unknown
Registered
2009-09-17
Start date
2007-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Interventions

Group A:Peginterferon alpha-2a
Group B:Entecavir

Sponsors

Guangdong General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. The study subjects were HBeAg-positive chronic HBV infected patients whose ALT=106 copies/ml over 3 times within 1 year follow-up period and hepatic histological inflammation G>=2 within 1 month. Diagnostic criteria and liver histological inflammation activity (G) grading criteria were based on the "Chinese viral hepatitis prevention and treatment guideline-2000 Edition"; 2. Both male and female subjects between 16 and 50 years of age without history of interferon or nucleoside analogue antiviral therapy; 3. Informed consent forms voluntarily signed.

Exclusion criteria

Exclusion criteria: 1. Medical history of ALT>2X ULN and concomitant infection of HAV, HCV, HDV or other types of viral hepatitis; complications of hepatic cirrhosis, hepatocellular carcinoma, metabolic liver diseases or autoimmune hepatitis; 2. Gestation or lactation; 3. History of alcoholic and/or drug abuse within 1 year prior to study; 4. Comorbidity of other serious diseases (e.g. malignancies, severe cardiac, pulmonary, renal and digestive disorders, mental disorders, hyperthyroidism, and diabetes mellitus).

Design outcomes

Primary

MeasureTime frame
Level of HBV-DNA;Level of HBeAg;Liver histological test;

Countries

China

Contacts

Public ContactXiaoping Chen
xiaopchen2003@yahoo.com.cn+86 13602869729

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026