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Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Primary Purpose

Chronic Hepatitis C Virus Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sofosbuvir + Simeprevir + Ribavirin
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus Infection focused on measuring Egyptian patients, HCV GT4, Naive, Ribavirin, Simeprevir, Sofosbuvir, Experinced

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with plasma HCV RNA level >10,000 IU/L for the two groups.
  • Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
  • Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV

Exclusion Criteria:

  • coinfected with hepatitis B virus or human immunodeficiency virus infection,
  • any cause of liver disease other than HCV GT4 infection;
  • liver decompensation,
  • hepatocellular carcinoma,
  • major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C >9)
  • Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count <50,000 cells/mm3)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    SOF + RBV (Naive)

    SOF + RBV (Experienced)

    SOF + SMV (Naive)

    SOF + SMV (Expereined)

    Arm Description

    For treatment-naive participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).

    For treatment-experienced participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).

    For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.

    For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With HCV 12
    HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).
    Number of Participants With Adverse Events
    An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study. A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity

    Secondary Outcome Measures

    Percentage of Participants With Virologic relapse
    Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT
    Percentage of Participants With Virologic null response
    Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period

    Full Information

    First Posted
    May 9, 2020
    Last Updated
    May 9, 2020
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04385407
    Brief Title
    Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients
    Official Title
    Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (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
    A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).
    Detailed Description
    A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C Virus Infection
    Keywords
    Egyptian patients, HCV GT4, Naive, Ribavirin, Simeprevir, Sofosbuvir, Experinced

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SOF + RBV (Naive)
    Arm Type
    Active Comparator
    Arm Description
    For treatment-naive participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).
    Arm Title
    SOF + RBV (Experienced)
    Arm Type
    Active Comparator
    Arm Description
    For treatment-experienced participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).
    Arm Title
    SOF + SMV (Naive)
    Arm Type
    Active Comparator
    Arm Description
    For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.
    Arm Title
    SOF + SMV (Expereined)
    Arm Type
    Active Comparator
    Arm Description
    For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.
    Intervention Type
    Drug
    Intervention Name(s)
    Sofosbuvir + Simeprevir + Ribavirin
    Other Intervention Name(s)
    Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With HCV 12
    Description
    HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).
    Time Frame
    12 weeks after last dose
    Title
    Number of Participants With Adverse Events
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study. A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity
    Time Frame
    up for 12 weeks after planned EOT.
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Virologic relapse
    Description
    Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT
    Time Frame
    12 weeks after the last dose
    Title
    Percentage of Participants With Virologic null response
    Description
    Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period
    Time Frame
    24 or 36 weeks stating from the first dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants with plasma HCV RNA level >10,000 IU/L for the two groups. Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy. Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV Exclusion Criteria: coinfected with hepatitis B virus or human immunodeficiency virus infection, any cause of liver disease other than HCV GT4 infection; liver decompensation, hepatocellular carcinoma, major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C >9) Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count <50,000 cells/mm3)

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30598598
    Citation
    Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Elbary AAA, Ramadan M. Sofosbuvir in combination with ribavirin or simeprevir: real-life study of patients with hepatitis C genotype 4. Ann Gastroenterol. 2019 Jan-Feb;32(1):93-98. doi: 10.20524/aog.2018.0327. Epub 2018 Nov 24.
    Results Reference
    result
    Links:
    URL
    http://www.annalsgastro.gr/files/journals/1/earlyview/2018/ev-11-2018-08-AG4308-0327.pdf
    Description
    This link describes the effectiveness and safety of two regimens sofosbuvir (SOF) in combination with either ribavirin (RBV) or simeprevir (SMV) in chronic hepatitis C (CHC) genotype (GT) 4 patients in Egypt.

    Learn more about this trial

    Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

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