Combination Treatment of NAs and Peg IFN α-2b for Hepatitis B Related, Compensatory Cirrhosis Patients

June 19, 2019 updated by: Lin Bingliang, Sun Yat-sen University

Combination Treatment of Nucleoside （Acid）Analogue (NAs) and Pegylated Interferon α-2b for NAs Treated, Hepatitis B Related, Compensatory Cirrhosis Patients With Low Level Hepatitis b Virus Surface Antigen (HBsAg)

The study aims to demonstrate that whether treatment of nucleoside （acid）analogues (NAs) plus pegylated interferon (Peg IFN) α-2b for those NAs treated, low level of HBsAg, hepatitis B related compensatory cirrhosis patients will result in higher HBsAg clearance rate and reduce the risk of liver cancer. The investigators plan to enroll about 84 hepatitis B related compensatory cirrhosis patients, who have received NAs treatment more than 1 year with the level of HBsAg <1000IU/ml. These participants will be devided into 2 groups. Group A will receive the treatment of NAs plus Peg IFNα-2b. Group B will be treated with NAs as before enrollment. The participants in both groups will be followed up for 96 weeks.

The primary endpoint is to compare the clearance rate of HBsAg between two groups. The secondary endpoint includes: (1) comparing the incidence of liver cancer during the 96 weeks follow-up, (2) comparing adverse side effects between the 2 groups. (3) comparing the virological and biochemical responses between the 2 groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Clearance of hepatitis B virus surface antigen (HBsAg) is considered to be the ultimate therapeutic goal for hepatitis B patients, for it is related with low incidence of fibrosis and liver cancer. The investigators' previous study show that nucleoside （acid）analogues (NAs) treated, non-cirrhosis hepatitis B patients switched to /or combined with pegylated interferon (Peg IFN)α-2b could obtain a higher HBsAg clearance rate. Hence, the investigators' hypothesis is that treatment of NAs plus Peg IFNα-2b for those NAs treated, low level of HBsAg, hepatitis B related compensatory cirrhosis patients result in higher HBsAg clearance rate and reduce the risk of liver cancer.

The investigators plan to enroll about 84 hepatitis B related compensatory cirrhosis patients, who have received NAs treatment more than 1 year with the level of HBsAg <1000IU/ml. These participants will be devided into 2 groups according to their wishes. Group A will receive the treatment of NAs (patients previously treated with telbivudine will be changed to entecavir) plus Peg IFNα-2b （180ug per week, the dose will be changed to 135ug or 90ug per week during the treatment if patients could not tolerate the side effects of Peg IFNα-2b）. Peg IFNα-2b treatment will be performed until HBsAg <0.05IU/ml, with a maximum duration of 48 weeks. Group B will be treated with NAs as before enrollment. The participants in both groups will be followed up for 96 weeks.

The primary endpoint is to compare the clearance rate of HBsAg between two groups. The secondary endpoint includes: (1) comparing the incidence of liver cancer during the 96 weeks follow-up, (2) comparing adverse side effects, such as ascites, gastrointestinal bleeding, encephalopathy, hepatorenal syndrome between the 2 groups. (3) comparing the virological and biochemical responses between the 2 groups.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

  • Name: Bingliang Lin, Doctor
  • Phone Number: 86-020-85253165
  • Email: lamikin@126.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affliated Hospital of Sun Yat-sen University
        • Contact:

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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 16-65 years old; Clinical diagnosis of compensatory cirrhosis; Child-Pugh grade A; Positive serum hepatitis B surface antigen (HBsAg); HBsAg titer < 1000IU/ml; Treated by nucleoside （acid）analogues (NAs) more than 1 year; HBV DNA <20 IU/ml; Negative serum hepatitis B e antigen (HBeAg); 15 minutes retention rate of indocyanine green <10%; The blood routine examination: 4×10e9/L<WBC<10×10e9/L、100×10e9/L<PLT<300×10e9/L.

Exclusion Criteria:

  • Treated by interferon within half a year; Drug induce liver diseases; Autoimmune liver diseases; Liver diseases caused by metabolic factors; Superinfection with hepatitis A, C, D, E viruses; Infected by HIV virus; Severe respiratory diseases; Severe circulatory diseases, ; Severe digestive diseases; Severe neurological diseases; Need for immunosuppressive therapy for other diseases; Need for radiotherapy/chemotherapy for other diseases; Thyroid diseases; Rheumatic diseases; Malignant tumors; Severe varicose esophageal and gastric fundus veins; Mental or psychological disorders; Alcohol or drug abusers (average alcohol consumption >40g/d for men, >20g/d for women); With contraindications to interferon therapy; Pregnancy or having pregnancy plan in 3 years; Lactation; Can not comply with the study protocol; Fail to sign the informed consent; Other conditions that are not suitable for enrollment determined by researchers.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAs+Peg IFN Group
NAs+Peg IFN Group will receive the treatment of NAs (patients previously treated with telbivudine will be changed to entecavir) plus pegylated interferon (Peg IFN)α-2b.
Drug: pegylated interferon (Peg IFN)α-2b
Participants in NAs+Peg IFN Group will be treated by Peg IFNα-2b （180ug per week, the dose will be changed to 135ug or 90ug per week during the treatment if patients could not tolerate the side effects of Peg IFNα-2b). Peg IFNα-2b treatment will be performed until HBsAg <0.05IU/ml, with a maximum duration of 48 weeks.
Other Names:
  • Pi Gebin
Drug: Nucleoside （acid）analogue (NAs)
Both of NAs Group and NAs+Peg IFN Group will be treated with NAs as before enrollment.
Other Names:
  • Boludine
Other: NAs Group
NAs Group will be treated with NAs as before enrollment.
Drug: Nucleoside （acid）analogue (NAs)
Both of NAs Group and NAs+Peg IFN Group will be treated with NAs as before enrollment.
Other Names:
  • Boludine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clearance rate of HBsAg for both groups during 96 weeks.
Time Frame: 96 weeks
The clearance rate of HBsAg will be compared between 2 groups.
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of liver cancer for both groups during 96 weeks
Time Frame: 96 weeks
The incidence of liver cancer will be compared between 2 groups.
96 weeks
Occurance rate of adverse side effects in both groups
Time Frame: 96 weeks
Adverse side effects, such as ascites, gastrointestinal bleeding, encephalopathy, hepatorenal syndrome will be compared between 2 groups
96 weeks
The change of liver functions in both groups
Time Frame: 96 weeks
The levels of alanine transaminase, glutamic-oxalacetic transaminase, albumin, total bilirubin, INR will be compared between the 2 groups.
96 weeks
The change of blood routine test indexes in both groups
Time Frame: 96 weeks
The levels of WBC, Hb, PLT will be compared between the 2 groups.
96 weeks

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Bingliang Lin, Doctor, Third Affiliated Hospital, Sun Yat-Sen University

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 (Actual)

June 17, 2019

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

May 30, 2024

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-CURE VI STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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