Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Treatments: Entecavir; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• Male and female patients > 18 and ≤ 60 years of age;

• Positive HBsAg for more than 6 months;

• Patients receiving previous ETV therapy ≥2 years;

• Patients who have achieved undetectable HBV DNA, HBsAg <1500IU/mL and HBeAg <200S/CO prior to switch or S-C therapy;

• ALT<=10*ULN and TB<2*ULN;

• Patients who have been assigned to treatment with PegIFN (S-C or switch) or continuous ETV after previous ETV therapy

Exclusion Criteria:

• Evidence of decompensated cirrhosis or hepatocellular carcinoma;

• Serological evidence of co-infection with HCV, HDV or HIV;

• Pregnant or breast-feeding women;

• Patients with diseases that might contraindicate to PegIFN therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc

• Patients receiving concomitant therapy with telbivudine;

• A history of drug or alcohol abuse;

• Other conditions that investigates consider not suitable for participate