Optimized Treatment of Peginterferon Alfa 2a/2b in Anti-virus Treatment Naive Patients With HBV Related Liver Fibrosis

Hepatitis B Clinical Trial

— HBV  

Official title:

Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Naive Patients With Hepatitis b Virus Related Liver Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03919565
• Other study ID #: PL4
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2019
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Wenxiong Xu, Doctor
• Phone: +8613760783281
• Email: xwx1983[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b 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 investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.

Description:

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment naive patients with HBV related liver fibrosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

2. Age from 18 to 55 years old;

3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;

4. Portal vein diameter = 12 mm from liver ultrasound;

5. Without treatment of anti-virus treatment ever before.

Exclusion Criteria:

1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;

2. Pregnancy or lactation;

3. Other active liver diseases;

4. Human immunodeficiency virus infection or congenital immune deficiency diseases;

5. Severe diabetes, autoimmune diseases;

6. Other important organ dysfunctions;

7. Patients can not follow-up.

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Drug:
• Tenofovir Disoproxil Fumarate
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
• Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 µg once per week.
• Peginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 µg once per week.

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of level of liver fibrosis after anti-virus treatment	Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment.	48 week, 144 week
Secondary	Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment	Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 6 time points after anti-virus treatment.	24 week, 48 week, 72 week, 96 week, 120 week,144 week
Secondary	Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment	Hepatitis b e antigen and hepatitis b e antibody would be tested to know the ratio of patients with negative hepatitis B e antigen and positive hepatitis B e antibody at 6 time points after anti-virus treatment.	24 week, 48 week, 72 week, 96 week, 120 week,144 week
Secondary	Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment	Hepatitis b surface antigen and hepatitis b surface antibody would be tested to know the ratio of patients with negative hepatitis B surface antigen and positive hepatitis B surface antibody at 6 time points after anti-virus treatment.	24 week, 48 week, 72 week, 96 week, 120 week,144 week