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Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4 (HCV)

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SOF/RBV/PegINFα-2
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring HCV genotype 4, sofosbuvir, Peg-interferon α-2, ribavirin, Egyptian patients, Experinced, Naive

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml.

Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.

-

Exclusion Criteria:Participants with one or more of

  • HCV coinfected with hepatitis B virus (HBV)
  • human immunodeficiency virus (HIV)
  • had any liver disease other than chronic HCV GT4 infection.
  • had a history of liver decompensation
  • serum a-fetoprotein (AFP) > 100 ng/ml
  • evidence of hepatocellular carcinoma
  • major severe illness such as respiratory, renal, heart failure or autoimmune disease
  • non-compliance with treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Treatment-naive

    Treatment-experienced

    Arm Description

    Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)

    Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < 15 IU/m 12 weeks after the last dose of drugs.
    Number of Participants With Adverse Events in Each Treatment Arm
    An adverse event (AE) is defined as any untoward medical occurrence in a participant or i clinical investigation after administering a pharmaceutical drugs serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity

    Secondary Outcome Measures

    Percentage of Participants With Viral relapse
    Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA > 15 IU/ml levels 12 weeks after planned EOT.
    Percentage of Participants With On-treatment Virologic Failure
    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml

    Full Information

    First Posted
    May 6, 2020
    Last Updated
    May 6, 2020
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04382339
    Brief Title
    Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4
    Acronym
    HCV
    Official Title
    Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beni-Suef University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
    Detailed Description
    Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: < 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks. Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C Virus Infection
    Keywords
    HCV genotype 4, sofosbuvir, Peg-interferon α-2, ribavirin, Egyptian patients, Experinced, Naive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment-naive
    Arm Type
    Active Comparator
    Arm Description
    Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)
    Arm Title
    Treatment-experienced
    Arm Type
    Active Comparator
    Arm Description
    Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)
    Intervention Type
    Drug
    Intervention Name(s)
    SOF/RBV/PegINFα-2
    Intervention Description
    SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
    Description
    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < 15 IU/m 12 weeks after the last dose of drugs.
    Time Frame
    12 weeks after last dose
    Title
    Number of Participants With Adverse Events in Each Treatment Arm
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant or i clinical investigation after administering a pharmaceutical drugs serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
    Time Frame
    Screening until 30 days after last dose
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Viral relapse
    Description
    Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA > 15 IU/ml levels 12 weeks after planned EOT.
    Time Frame
    12 weeks after last dose
    Title
    Percentage of Participants With On-treatment Virologic Failure
    Description
    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml
    Time Frame
    up tp 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml. Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy. - Exclusion Criteria:Participants with one or more of HCV coinfected with hepatitis B virus (HBV) human immunodeficiency virus (HIV) had any liver disease other than chronic HCV GT4 infection. had a history of liver decompensation serum a-fetoprotein (AFP) > 100 ng/ml evidence of hepatocellular carcinoma major severe illness such as respiratory, renal, heart failure or autoimmune disease non-compliance with treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammed Abdel-Gabbar, Ass. Prof
    Organizational Affiliation
    Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30324144
    Citation
    Abdel-Moneim A, Abood A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients. Clin Exp Hepatol. 2018 Sep;4(3):191-196. doi: 10.5114/ceh.2018.78123. Epub 2018 Sep 10.
    Results Reference
    result
    Links:
    URL
    https://www.termedia.pl/Effectiveness-of-sofosbuvir-pegylated-interferon-plus-ribavirin-in-treatment-of-hepatitis-C-virus-genotype-4-patients,80,33652,0,1.html
    Description
    The link clarify the effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients

    Learn more about this trial

    Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

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