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Trial record 4 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: 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
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm
Elbasvir, Grazoprevir 50-100Mg Oral Tablet
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)




Primary Outcome Measures :
  1. 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.)



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03578640


Contacts
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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

Locations
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Saudi Arabia
King Fahad Medical City
Riyadh, Saudi Arabia, 11525
Contact: Omar H Kasule, PhD    +966 11 288 9999 ext 26913    okasule@kfmc.med.sa   
Contact: Isamme N AlFayyad, MA BioEthics    +966 11 288 9999 ext 10848    ialfayyad@kfmc.med.sa   
Principal Investigator: Ahmad A AlEid, Consultant         
Sub-Investigator: Abdullah A AlKhathlan, Consultant         
Sub-Investigator: Areej N Al Balkhi, MBBS         
Sub-Investigator: Adel Al Qutub, Consultant         
Sponsors and Collaborators
King Fahad Medical City

Additional Information:
Publications of Results:
Serfaty L, Zeuzem S, Vierling JM, et al. High efficacy of the combination HCV regimen grazoprevir and elbasvir for 8 or 12 weeks with or without ribavirin in treatment-naive, noncirrhotic HCV GT1b-infected patients: an integrated analysis. Program and abstracts of the 2015 Annual Meeting of the American Association for the Study of Liver Diseases; November 13-17, 2015; San Francisco, California. Abstract 701.
STREAGER Interim Analysis: High Rate of SVR With 8 Weeks of Elbasvir/Grazoprevir in Treatment-Naive Patients With Genotype 1b HCV Infection and F0-F2 Fibrosis; 2017 Annual Meeting of the American Association for the Study of Liver Diseases; Washington DC; Posted online October 27, 2017.

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Responsible Party: Ahmad A AlEid, MD, Staff Physician, Department of Gastroenterology and Hepatology, Consultant Advanced Hepatology and Liver Transplantation, Principal Investigator of the ELEGANT-4 trial, King Fahad Medical City
ClinicalTrials.gov Identifier: NCT03578640    
Other Study ID Numbers: 18-226
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
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 Ahmad A AlEid, MD, King Fahad Medical City:
Hepatitis C Virus
Chronic Hepatitis C
Genotype 4
Treatment-naive
Non-cirrhotic
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents