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Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4 (ELEGANT-4)

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ClinicalTrials.gov Identifier: NCT03578640
Recruitment Status : Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmad A AlEid, MD, King Fahad Medical City

Tracking Information
First Submitted Date  ICMJE June 6, 2018
First Posted Date  ICMJE July 6, 2018
Last Update Posted Date July 6, 2018
Estimated Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
Sustained virologic response at 12 weeks after the end of intervention (SVR-12). [ Time Frame: At 12 weeks after the end of intervention. ]
Viral RNA below the level of detection at 12 weeks after the end of the intervention. (Hepatitis C viral load evaluated by polymerase chain reaction (PCR) with a cutoff of 20 IU/mL for detectability.)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
  • Sustained virological response at 4 weeks after the end of intervention (SVR-4). [ Time Frame: At 4 weeks after the end of intervention. ]
    Hepatitis C viral RNA below the level of detection at 4 weeks after the end of the intervention.
  • Serious and treatment-related adverse events. [ Time Frame: From the first day of intervention until the end of week 4 after the intervention is finished. ]
    Number of patients with serious and treatment-related adverse events based on the common terminology criteria (CTCAE 4.03), or death during the follow-up period.
  • Prevalence of resistance associated substitutes (RASs) [ Time Frame: At 12 weeks after the end of intervention. ]
    The prevalence of resistance associated substitutes (RASs) at baseline in patients who fail to achieve the primary endpoint. This will be done in a retrospective manner as blood samples will be collected in a blood biobank prior to the therapy.
  • Prevalence of treatment emerging resistance associated variants (RAVs) [ Time Frame: At 12 weeks after the end of intervention. ]
    The prevalence of treatment emerging resistance associated variants (RAVs) in patients who fail to achieve the primary end point.
  • Changes in the quality of life: Hepatitis Quality of Life Questionnaire (HQLQ) [ Time Frame: Quality of life assessment of the patient's will take place over three occasions. The 1st will be a baseline assessment upon initiating the treatment, the 2nd will be at the last day of treatment, and the last will be 24 weeks after the end of treatment. ]
    To assess the patient's quality of life, we will be using a self-administered questionnaire called the "Hepatitis Quality of Life Questionnaire" (HQLQ). The questionnaire has questions that aim to evaluate how well the patient can do his/her usual activities. Overall, the higher the score, the better the quality of life. Assessment of the patient's quality of life will take place over three occasions. The first will be a baseline assessment upon initiating the treatment, the second will be at the last day of treatment (in other words, when the patient finishes the 8-week course), and the last will take place 24 weeks after the end of treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4
Official Title  ICMJE The Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, Non-Cirrhotic, HCV GT4-Infected Patients: A Single-Center, Single-Arm, Open-Label, Phase III Trial
Brief Summary To evaluate the safety and efficacy of a daily, fixed-dose, 8-week course combination of Elbasvir/Grazoprevir in treatment-naïve, non-cirrhotic patients who are mono-infected with hepatitis C, genotype 4.
Detailed Description

The treatment of hepatitis C has gone through significant advances in the last few years with the development of direct-acting antivirals "DAAs." Since 2013, many DAAs have been approved for the treatment of HCV with excellent efficacy and safety profiles. The major hurdle in treating patients on a large scale is the high cost of the current treatment regimens. Multiple approaches have been proposed, among them, a shortened treatment regimen of 6 to 8 weeks rather than the standard 12-week-regimen. The strategy of shortening the treatment will help in reducing the cost by 33% to 50%. Thus, it will increase the availability of the treatment to more patients.

Zepatier is a combination drug of Elbasvir (EBR), an NS5A inhibitor, and Grazoprevir (GZR), a potent NS3/4A inhibitor. This study is being proposed to address two main issues. First, collecting information on the safety and efficacy of a shortened course of zepatier (8 weeks instead of the standard 12 weeks) in patients who are treatment-naïve, non-cirrhotic and mono-infected with HCV. Second, to investigate whether this course provides similar clinical outcomes to the standard regimen in HCV-Genotype 4, which is the most common genotype in Saudi Arabia.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
An interventional, single-center, single-arm study among 30 patients who are treatment naïve, have no advanced fibrosis and mono-infected with HCV-GT4.
Masking: None (Open Label)
Masking Description:
Open-label
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet
Daily, fixed-dose combination of Elbasvir 50 mg and Grazoprevir 100 mg given in a single oral tablet for 8 weeks.
Other Name: Elbasvir / Grazoprevir Oral Tablet (Zepatier)
Study Arms  ICMJE Experimental: Treatment arm
Elbasvir, Grazoprevir 50-100Mg Oral Tablet
Intervention: Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age above 18 years.
  2. Chronically infected with HCV genotype 4.
  3. Treatment naïve.
  4. No advanced fibrosis. Defined by the absence of clinical, radiological and laboratory signs of cirrhosis, and fibrosis assessment consistent with fibrosis stage (Metavir F2) or less by liver biopsy or transient elastography.
  5. Not expected to leave the country for six months after the end of the intervention.

Exclusion Criteria:

  1. Incapability of providing an informed consent to participate in the study.
  2. Advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4).
  3. HIV or HBV co-infection
  4. Organ transplant recipients.
  5. Type 2 or 3 cryoglobulinemia with end-organ manifestations.
  6. Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis
  7. Patients with a higher risk of transmitting the disease (Dialysis patients, incarcerated individuals, and intravenous drug abusers).
  8. The use of any medication that has major interactions with Elbasvir or Grazoprevir as defined by the University of Liverpool drug interaction database, and cannot be discontinued or replaced with other alternatives.
  9. Pregnancy.
  10. History of hepatocellular carcinoma.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmad A AlEid, MBBS +966 11 2889999 ext 27636 ahaleid@kfmc.med.sa
Contact: Abdullah A Al Khathlan, MBBS +966 11 2889999 ext 27602 aKhathlan@kfmc.med.sa
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03578640
Other Study ID Numbers  ICMJE 18-226
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmad A AlEid, MD, King Fahad Medical City
Study Sponsor  ICMJE King Fahad Medical City
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account King Fahad Medical City
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP