Optimized Treatment of Peginterferon Alfa 2a/2b in Treatment Experienced Patients With HBV Related Liver Fibrosis (HBV)
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ClinicalTrials.gov Identifier: NCT03920605 |
Recruitment Status :
Recruiting
First Posted : April 19, 2019
Last Update Posted : May 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis B Liver Fibrosis | Drug: Tenofovir Disoproxil Fumarate Drug: Peginterferon Alfa-2a Drug: Peginterferon Alfa-2b | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Experienced Patients With Hepatitis b Virus Related Liver Fibrosis |
Actual Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | October 30, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
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Active Comparator: Peginterferon alfa group
50 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.
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Drug: Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Other Name: Pegasys Drug: Peginterferon Alfa-2b Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Other Name: Pegintron |
Active Comparator: Combination group
50 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week and meanwhile oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive treatment of oral TDF 300 mg once per day from 49 to 144 weeks.
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Drug: Tenofovir Disoproxil Fumarate
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
Other Name: Viread Drug: Peginterferon Alfa-2a Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Other Name: Pegasys Drug: Peginterferon Alfa-2b Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Other Name: Pegintron |
- Change of level of liver fibrosis after anti-virus treatment [ Time Frame: 48 week, 144 week ]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.
- Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment [ Time Frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week ]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.
- Ratio of patients with hepatitis b e antigen seroconversion after anti-virus treatment [ Time Frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week ]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.
- Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment [ Time Frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week ]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.

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Ages Eligible for Study: | 15 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 55 years old;
- Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
- Portal vein diameter ≤ 12 mm from liver ultrasound;
- Receiving treatment of nucleoside/nucleotide analogues at the past one year;
- Normal liver function;
- Undetectable hepatitis b virus DNA.
Exclusion Criteria:
- Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Other active liver diseases;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
- Other important organ dysfunctions;
- Patients can not follow-up;
- Investigator considering inappropriate.

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): NCT03920605
Contact: Wenxiong Xu, Doctor | +8613760783281 | xwx1983@163.com | |
Contact: Liang Peng, Doctor | +8613533978874 | pzp33@hotmail.com |
China, Guangdong | |
Third Affiliated Hospital of Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510630 | |
Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com |
Principal Investigator: | Liang Peng, Doctor | Third Affiliated Hospital of Sun Yat-sen University |
Responsible Party: | Liang Peng, Professor, Third Affiliated Hospital, Sun Yat-Sen University |
ClinicalTrials.gov Identifier: | NCT03920605 |
Other Study ID Numbers: |
PL5 |
First Posted: | April 19, 2019 Key Record Dates |
Last Update Posted: | May 22, 2019 |
Last Verified: | May 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
hepatitis b virus peginterferon alfa liver fibrosis |
Hepatitis A Hepatitis B Hepatitis Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Pathologic Processes |
Hepadnaviridae Infections DNA Virus Infections Tenofovir Peginterferon alfa-2a Peginterferon alfa-2b Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |