This trial is active, not recruiting.

Condition chronic hepatitis b
Treatment peginterferon alfa-2a
Phase phase 4
Sponsor Henan Provincial Hospital
Start date September 2016
End date June 2018
Trial size 114 participants
Trial identifier NCT02894918, COMBINE


This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study.

The CHB patients with NAs treatment and have achieved HBV DNA <15 IU/ml、HBeAg <100 PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml will be randomized into 2 groups:

Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week
peginterferon alfa-2a Pegasys
180ug/0.5ml,hypodermic injection once a week
(No Intervention)
Maintain NAs mono-therapy oral-daily for 48 weeks.

Primary Outcomes

The rate of HBsAg loss
time frame: 48 weeks

Secondary Outcomes

Decline of HBeAg quantification
time frame: 12 weeks, 24 weeks, 48 weeks of treatment
Decline of HBsAg quantification
time frame: 12 weeks, 24 weeks, 48 weeks of treatment
The rate of HBeAg loss
time frame: 48 weeks
The rate of HBeAg seroconversion
time frame: 48 weeks
The rate of HBsAg seroconversion
time frame: 48 weeks
Sustained virological response rate
time frame: 12 weeks, 24 weeks, 48 weeks of treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Male and female patients >18 and ≤65 years of age; - Diagnosed chronic hepatitis B (HBsAg(+) for over 6 months before nucleos(t)ide analogues treatment) - Patients had achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml on treatment of Nucleoside (acid) Analogues (including LAM, ADV, ETV, and TDF ) Exclusion Criteria: - Decompensated liver disease: including ascites, hepatic encephalopathy, esophagogastric-varicosis and fissure bleeding and other decompensated complication; - Hypersensitive to interferon(IFN) or its active substance, and ineligible to IFN; - A history of immunoregulation drug therapy within 1 year before entry including IFN and so on; - Coinfection with HAV、HCV、HDV、HEV 、HIV or with Other chronic liver diseases such as Alcoholic Liver Disease,Inherited Metabolic Liver Disease,Drug induced Liver Disease and nonalcoholic fatty liver, autoimmune disease including autoimmune hepatitis and Psoriasis and so on; - Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months; - A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter; - A serum creatinine level that was more than 1.5 times the upper limit of the normal range; - With other malignant tumors(exclude the cured ones); - Severe organ dysfunction; - With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on; - Uncontrolled diabetes, hypertension or thyroid disease; - Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period; - Participate in other clinical studies at the same time; - Patients unsuitable for the research;

Additional Information

Official title A Randomized, Open-label, Multi-center Clinical Trial to Evaluate Addition of Peginterferon Alfa-2a to CHB Patients Treated With NAs and Achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg Positive and HBsAg<1500 IU/ml.
Principal investigator Jia Shang, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Henan Provincial Hospital.