- Solid Tumors
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03919565
Recruitment Status Recruiting
First Posted April 18, 2019
Last update posted April 19, 2019
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.
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.
|Active Comparator: TDF group
80 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 144 weeks.
Drug: Tenofovir Disoproxil Fumarate
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
|Experimental: Peginterferon alfa group
40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.
Drug: Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Drug: Peginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
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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.
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.
Contact: Wenxiong Xu, Doctor +8613760783281 firstname.lastname@example.org
Contact: Liang Peng, Doctor +8613533978874 email@example.com
Third Affiliated Hospital of Sun Yat-sen University
Third Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital of Sun Yat-sen University