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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03919565

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted April 19, 2019

Study Description

Brief 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.

  • Condition or Disease:Hepatitis B
    Liver Fibrosis
  • Intervention/Treatment: Drug: Tenofovir Disoproxil Fumarate
    Drug: Peginterferon Alfa-2a
    Drug: Peginterferon Alfa-2b
  • Phase: N/A
Detailed 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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 120 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 Naive Patients With Hepatitis b Virus Related Liver Fibrosis
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Wenxiong Xu, Doctor +8613760783281 xwx1983@163.com

Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com

Locations

China, Guangdong
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou

Sponsors and Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital of Sun Yat-sen University

More Information
  • Responsible Party: Third Affiliated Hospital, Sun Yat-Sen University
  • ClinicalTrials.gov Identifier: NCT03919565 History of Changes
  • Other Study ID Numbers: PL4
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 19, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University: hepatitis b virus
    peginterferon alfa
    liver fibrosis
  • Additional relevant MeSH terms: Hepatitis A
    Hepatitis
    Hepatitis B
    Liver Cirrhosis
    Fibrosis