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

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ClinicalTrials.gov Identifier: NCT03969017
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Lin Bingliang, Sun Yat-sen University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cirrhosis of Liver Due to Hepatitis B (Disorder) Drug: pegylated interferon (Peg IFN)α-2b Drug: Nucleoside (acid)analogue (NAs) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

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 Name: 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 Name: Boludine

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 Name: Boludine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969017


Contacts
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Contact: Bingliang Lin, Doctor 86-020-85253165 lamikin@126.com
Contact: Junfeng Chen, Master 86-020-85253165 mountainchen@139.com

Locations
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China, Guangdong
Third Affliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Lin Bingliang, MD    86-20-85253165    lamikin@126.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Bingliang Lin, Doctor Third Affiliated Hospital, Sun Yat-Sen University

Publications:

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Responsible Party: Lin Bingliang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03969017     History of Changes
Other Study ID Numbers: I-CURE VI STUDY
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatitis
Hepatitis A
Hepatitis B
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents