A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs

NCT ID: NCT02894918

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-12-31

Brief Summary

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination group

Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week

Group Type: EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type: DRUG

180ug/0.5ml,hypodermic injection once a week

Mono NA group

Maintain NAs mono-therapy oral-daily for 48 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peginterferon alfa-2a

180ug/0.5ml,hypodermic injection once a week

Intervention Type: DRUG

Other Intervention Names

Pegasys

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiashang

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jia Shang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henan People's hospital

Locations

Kaifeng Central Hospitl

Kaifeng, Henan, China

Weishi County People's Hospital

Kaifeng, Henan, China

Luoyang Central Hospital

Luoyang, Henan, China

Shangqiu No.1 People's Hospital

Shangqiu, Henan, China

Henan People's Hospital

Zhengzhou, Henan, China

Countries

China

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Other Identifiers

COMBINE

Identifier Type: -

Identifier Source: org_study_id