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ClinicalTrials.gov ID

NCT02589652

Lead Sponsor

Huashan HospitalOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

294Estimated

Last Update Posted

Oct 28, 2015Estimated

Start Date

Oct 2015

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

Official Title

Efficacy of Switch or Sequential Combination Therapy of Pegylated Interferon Alfa-2a in Chronic Hepatitis B Patients With Low HBsAg and HBeAg Titers After Long-term Entecavir Therapy: A Multicenter, Prospective Cohort Study

Brief 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.

Detailed Description

Chronic hepatitis B (CHB) infection remains a global health treat. The ideal end point of therapy is HBsAg loss or HBsAg seroconversion, indicating a complete remission of CHB. In patients with HBeAg-positive CHB, sustained HBeAg seroconversion is also a desirable end point. Current therapies include pegylated interferon (PegIFN) finite and nucleos(t)ide analogues (NUCs) longterm therapy. However, only 30-40% of patients may achieve HBeAg seroconversion on PegIFN monotherapy, whereas 15-20% of patients on entecavir (ETV). Recently, accumulating evidence had shown that optimization of switching or combining PegIFN in patients on long-term ETV therapy may increase rate of HBeAg seroconversion and even lead to the complete eradication of HBV. However, these two regimens has not been tested adequately in patients with low HBsAg/HBeAg titers on long-term ETV therapy.

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.

• Chronic Hepatitis B

• Pegylated interferon alfa-2a
• Pegylated interferon alfa-2a plus Entecavir
• Entecavir

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Huashan HospitalOTHER

xieyao@public.bta.net.cn

zhuchw@126.com

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