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Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

Primary Purpose

Chronic Hepatitis C Virus Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
(SOF and DCV)
(SOF, DCV, and RBV)
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 Sofosbuvir, Daclatasvir, Ribavirin, HCV GT 4

Eligibility Criteria

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

Inclusion Criteria:

  • Non-cirrhotic treatment-naïve participants
  • FIB-4 < 3.25
  • albumin > 3.5
  • total bilirubin < 1.2 mg/dl
  • international normalized ratio (INR) < 1.2
  • platelet count > 150,000 mm3.
  • experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
  • Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis

Exclusion Criteria:

  • liver disease of non-HCV etiology
  • hepatitis B or human immune-deficiency virus (HIV) infection
  • poorly controlled diabetic (HbA1C > 9) participants
  • hepatocellular carcinoma
  • a history of extra-hepatic malignancy within 5 years prior to the study
  • pregnant or breast feeding
  • renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min
  • evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl
  • blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3)
  • major severe illnesses such as congestive heart failure and respiratory failure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    SOF/DCV

    SOF/DCV/RBV + Cirrhosis

    SOF/DCV/RBV + Non-Cirrhosis

    Arm Description

    Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks. This arm included non-cirrhotic treatment-naïve patients

    This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.

    This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.

    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) level < 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 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 level ≤ 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 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 10, 2020
    Last Updated
    May 13, 2020
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04387526
    Brief Title
    Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
    Official Title
    Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    May 31, 2017 (Actual)
    Study Completion Date
    May 31, 2017 (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 evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
    Detailed Description
    Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks. SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.

    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
    Sofosbuvir, Daclatasvir, Ribavirin, HCV GT 4

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    946 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SOF/DCV
    Arm Type
    Active Comparator
    Arm Description
    Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks. This arm included non-cirrhotic treatment-naïve patients
    Arm Title
    SOF/DCV/RBV + Cirrhosis
    Arm Type
    Active Comparator
    Arm Description
    This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.
    Arm Title
    SOF/DCV/RBV + Non-Cirrhosis
    Arm Type
    Active Comparator
    Arm Description
    This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    (SOF and DCV)
    Other Intervention Name(s)
    Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir
    Intervention Type
    Drug
    Intervention Name(s)
    (SOF, DCV, and RBV)
    Other Intervention Name(s)
    Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir
    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) level < 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 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
    up for 12 weeks after planned End of Treatment (EOT).
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Viral relapse
    Description
    Viral relapse was HCV RNA level ≤ 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 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
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non-cirrhotic treatment-naïve participants FIB-4 < 3.25 albumin > 3.5 total bilirubin < 1.2 mg/dl international normalized ratio (INR) < 1.2 platelet count > 150,000 mm3. experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis Exclusion Criteria: liver disease of non-HCV etiology hepatitis B or human immune-deficiency virus (HIV) infection poorly controlled diabetic (HbA1C > 9) participants hepatocellular carcinoma a history of extra-hepatic malignancy within 5 years prior to the study pregnant or breast feeding renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3) major severe illnesses such as congestive heart failure and respiratory failure.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29754329
    Citation
    Abdel-Moneim A, Aboud A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int. 2018 Jul;12(4):348-355. doi: 10.1007/s12072-018-9868-8. Epub 2018 May 12.
    Results Reference
    result
    Links:
    URL
    https://doi.org/10.1007/s12072-018-9868-8
    Description
    This link describes the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian patients infected with HCV GT4.

    Learn more about this trial

    Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

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