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Trial record 15 of 25 for:    "Liver Cirrhosis" | "Peginterferon alfa-2a"

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
Sponsor:
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

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 experienced patients with HBV related liver fibrosis.

Condition or disease Intervention/treatment Phase
Hepatitis B Liver Fibrosis Drug: Tenofovir Disoproxil Fumarate Drug: Peginterferon Alfa-2a Drug: Peginterferon Alfa-2b Not Applicable

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 experienced patients with HBV related liver fibrosis.

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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
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.
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.
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




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.



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Ages Eligible for Study:   15 Years to 55 Years   (Child, 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. Receiving treatment of nucleoside/nucleotide analogues at the past one year;
  6. Normal liver function;
  7. Undetectable hepatitis b virus DNA.

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;
  8. Investigator considering inappropriate.

Information from the National Library of Medicine

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


Contacts
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Contact: Wenxiong Xu, Doctor +8613760783281 xwx1983@163.com
Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com

Locations
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China, Guangdong
Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Liang Peng, Doctor    +8613533978874    pzp33@hotmail.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital of Sun Yat-sen University

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Responsible Party: Liang Peng, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03920605     History of Changes
Other Study ID Numbers: PL5
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University:
hepatitis b virus
peginterferon alfa
liver fibrosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Peginterferon alfa-2a
Hepatitis A
Hepatitis B
Hepatitis
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
Interferon-alpha
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
Immunologic Factors
Physiological Effects of Drugs