Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis

NCT ID: NCT03957629

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2023-07-30

Brief Summary

Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.

Detailed Description

Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.

Main purpose: Comparing the improvement rate of liver fibrosis. Secondary purpose: Comparing the incidence of adverse events. Comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure.

Comparing the rates of HBsAg and HBeAg serological conversion.

Conditions

Hepatitis B; Liver Fibrosis

Study Design

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

Study Groups

TDF group

93 patients would receive treatment of oral medication of tenofovir disoproxil fumarate (TDF) 300mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.

Group Type: ACTIVE_COMPARATOR

Tenofovir Disoproxil Fumarate

Intervention Type: DRUG

Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.

Combination group

93 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg once per week and meanwhile oral medication of tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.

Group Type: ACTIVE_COMPARATOR

Tenofovir Disoproxil Fumarate

Intervention Type: DRUG

Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.

PEG-Interferon alfa 2a

Intervention Type: DRUG

Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.

Interventions

Tenofovir Disoproxil Fumarate

Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.

Intervention Type: DRUG

PEG-Interferon alfa 2a

Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.

Intervention Type: DRUG

Other Intervention Names

Viread; Beixin; Pegasys

Eligibility Criteria

Inclusion Criteria

1. Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;

2. Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited;

3. Age from 18 to 55 years old;

4. Normal liver function(ALT<ULN,AST<ULN and TBil<ULN).

5. Undetectable hepatitis b virus DNA or less than 100IU/ml.

6. LSM between 6 and 12 kpa measured by fibroscan;

7. Liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm.

Exclusion Criteria

1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;

2. Pregnancy, lactation or female has plan of pregnancy within 18 months;

3. Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)；

4. Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases;

5. Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions;

6. Patients who fail to comply with this research arrangement and sign an informed consent form

7. Patients can not follow-up;

8. Investigator considering inappropriate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Liang Peng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peng, ph.D.

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

Xu, ph.D.

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shu Zhu, Master

Role: CONTACT

zhush8@mail2.sysu.edu.cn

+8615626477267

Facility Contacts

Liang Peng, Doctor

Role: primary

pzp33@hotmail.com

+8613533978874

Other Identifiers

PL7

Identifier Type: -

Identifier Source: org_study_id