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Trial record 45 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis

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ClinicalTrials.gov Identifier: NCT03957629
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
Compared to TDF, peginterferon alfa 2a 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 in TDF experienced patients with HBV related liver fibrosis.

Condition or disease Intervention/treatment Phase
Hepatitis B Liver Fibrosis Drug: Tenofovir Disoproxil Fumarate Drug: PEG-Interferon alfa 2a Not Applicable

Detailed Description:
Compared to TDF, peginterferon alfa 2a 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 treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a, comparing to TDF, in TDF experienced patients with HBV related liver fibrosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on Optimized Treatment of Peginterferon Alfa 2a in TDF Experienced Patients With Hepatitis b Virus Related Liver Fibrosis
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Active Comparator: TDF group
93 patients would receive treatment of oral medication of tenofovir disoproxil fumarate (TDF) 300mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.
Drug: Tenofovir Disoproxil Fumarate
Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.
Other Names:
  • Viread
  • Beixin

Active Comparator: Combination group
93 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg once per week and meanwhile oral medication of tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.
Drug: Tenofovir Disoproxil Fumarate
Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.
Other Names:
  • Viread
  • Beixin

Drug: PEG-Interferon alfa 2a
Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Other Name: Pegasys




Primary Outcome Measures :
  1. Ratio of regression of fibrosis [ Time Frame: 48 weeks; 96 weeks ]
    Regression of fibrosis was defined as the degree of hepatic fibrosis changed from F3 to F2 or below, or F2 to F1 or below, or F1 to F0. After treatment, the proportion of patients with regression of fibrosis in the two groups was the ratio of regression of fibrosis, separately.


Secondary Outcome Measures :
  1. Ratio of loss of hepatitis b e antigen or/and seroconversion [ Time Frame: 24 week, 48 week, 72 week, 96 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 4 time points after anti-virus treatment.

  2. Ratio of loss of hepatitis b s antigen or/and seroconversion [ Time Frame: 24 week, 48 week, 72 week, 96 week ]
    Hepatitis b s antigen and hepatitis b s antibody would be tested to know the ratio of patients with negative hepatitis B s antigen and positive hepatitis B s antibody at 4 time points after anti-virus treatment.

  3. Logarithmic mean of HBsAg decline [ Time Frame: 24 week, 48 week, 72 week, 96 week ]
    Hepatitis b s antigen would be tested to know the decline of patients with positive hepatitis B s antigen at 4 time points after anti-virus treatment.



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Ages Eligible for Study:   18 Years 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. Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited;
  3. Age from 18 to 55 years old;
  4. Normal liver function(ALT<ULN,AST<ULN and TBil<ULN).
  5. Undetectable hepatitis b virus DNA or less than 100IU/ml.
  6. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
  7. Liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm.

Exclusion Criteria:

  1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
  2. Pregnancy, lactation or female has plan of pregnancy within 18 months;
  3. Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.);
  4. Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases;
  5. Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions;
  6. Patients who fail to comply with this research arrangement and sign an informed consent form
  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): NCT03957629


Contacts
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Contact: Shu Zhu +8615626477267 zhush8@mail2.sysu.edu.cn

Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Liang Peng, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03957629     History of Changes
Other Study ID Numbers: PL7
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
liver fibrosis
peg interferon alfa-2a
tenofovir disoproxil fumarate
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
DNA Virus Infections
Peginterferon alfa-2a
Hepatitis A
Hepatitis B
Hepatitis
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Pathologic Processes
Hepadnaviridae Infections
Interferons
Tenofovir
Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
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