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

September 8, 2016 updated by: Jiashang, Henan Provincial People's Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Kaifeng, Henan, China
        • Kaifeng Central Hospitl
      • Kaifeng, Henan, China
        • Weishi County People's Hospital
      • Luoyang, Henan, China
        • Luoyang Central Hospital
      • Shangqiu, Henan, China
        • Shangqiu No.1 People's Hospital
      • Zhengzhou, Henan, China
        • Henan People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination group
Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week
Drug: Peginterferon alfa-2a
180ug/0.5ml,hypodermic injection once a week
Other Names:
  • Pegasys
No Intervention: Mono NA group
Maintain NAs mono-therapy oral-daily for 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of HBsAg loss
Time Frame: 48 weeks
To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decline of HBeAg quantification
Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment
Quantitative HBeAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml).
12 weeks, 24 weeks, 48 weeks of treatment
Decline of HBsAg quantification
Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment
Quantitative HBsAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL).
12 weeks, 24 weeks, 48 weeks of treatment
The rate of HBeAg loss
Time Frame: 48 weeks
48 weeks
The rate of HBeAg seroconversion
Time Frame: 48 weeks
48 weeks
The rate of HBsAg seroconversion
Time Frame: 48 weeks
48 weeks
Sustained virological response rate
Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment
Sustained virological response rate will be presented as rate of HBV DNA <15 IU/ml
12 weeks, 24 weeks, 48 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Provincial People's Hospital

Investigators

  • Principal Investigator: Jia Shang, M.D., Henan People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMBINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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