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EBR/GZR for HCV-1b Patients Receiving Hemodialysis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03420300
Recruitment Status : Completed
First Posted : February 5, 2018
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent safety profiles to treat patients with severe renal impairment. With regard to elbasvir/grazoprevir (EBR/GZR) treatment, a phase 3 study (C-SURFER) study has shown 99% of SVR in HCV-1 patients with chronic kidney disease (CKD) stage 4 or 5. Furthermore, most patients tolerated the treatment well. Although the data confirmed the excellent safety and efficacy in HCV-1 patients with severe renal impairment, data regarding the safety and efficacy for Asian HCV-1b patients receiving hemodialysis is lacking. Therefore, we aim to evaluated the safety and efficacy of EBR/GZR for 12 weeks in treatment-naive and treatment-experienced HCV-1b patients receiving hemodialysis.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: EBR/GZR Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elbasvir/Grazoprevir for Treatment-naive and Treatment-experienced Patients With Hepatitis C Virus Genotype 1b Receiving Hemodialysis
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : November 2, 2019
Actual Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EBR/GZR
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks
Drug: EBR/GZR
Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks
Other Name: Zepatier




Primary Outcome Measures :
  1. Sustained Virologic Response (SVR12) Rate [ Time Frame: 24 weeks ]
    Proportion of patients who had undetectable serum HCV RNA 12 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)


Secondary Outcome Measures :
  1. Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate [ Time Frame: 12 weeks ]
    Proportion of participants who withdrew from the study due to any adverse events (AEs) which were judged related to elbasvir/grazoprevir (EBR/GZR)

  2. Sustained Virologic Response (SVR24) Rate [ Time Frame: 36 weeks ]
    Proportion of patients who had undetectable serum HCV RNA 24 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)

  3. Rapid Virologic Response (RVR) Rate [ Time Frame: 4 weeks ]
    Proportion of patients who had undetectable serum HCV RNA at week 4 of elbasvir/grazoprevir (EBR/GZR) treatment

  4. End-of-treatment Virological Response (EOTVR) Rate [ Time Frame: 12 weeks ]
    Proportion of patients who had undetectable serum HCV RNA at the time point of treatment completion for elbasvir/grazoprevir (EBR/GZR)

  5. Week 12 Virologic Response (W12VR) [ Time Frame: 12 weeks ]
    Proportion of patients who completed 12 weeks of elbasvir/grazoprevir (EBR/GZR) treatment and who had undetectable serum HCV RNA at week 12 of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 yeas or more
  • Male or female
  • Body mass index (BMI) 18.5-35.0 kg/m2
  • Chronic HCV infection, defined as patients who meet as least one of the two following criteria:

    1. Anti-HCV antibody (Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) or HCV RNA > 1,000 IU/mL for at least 6 months before screening
    2. Positive HCV RNA > 1,0000 IU/mL (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, low limit of quantification (LLOQ): 25 IU/mL) at the time of screening with a liver biopsy consistent with chronic HCV infection
  • HCV genotype 1 (HCV GT-1b) infection (Abbott RealTime HCV genotype II, Abbott Molecular Inc. Illinois, USA)
  • Treatment-naïve or treatment-experienced (including patients who relapsed, who had virological breakthrough, or who were null-responsive to IFN-based therapies)
  • HCV RNA > 10,000 IU/mL at screening
  • Estimated glomerular filtration (eGFR) rate < 15 mL/min/1.73m2 as assessed by modified of diet in renal disease (MDRD) equation, and receiving regular hemodialysis

Exclusion Criteria:

  • HCV infection other than HCV GT-1b
  • HBV or HIV coinfection
  • Presence of decompensated cirrhosis (Child-Pugh class B or C)
  • Any primary cause of liver disease other than chronic HCV infection, including but not limited to the following

    1. Hemochromatosis
    2. Alfa-1 antitrypsin deficiency
    3. Wilson's disease
    4. Autoimmune hepatitis
    5. Alcoholic liver disease
    6. Drug-induced hepatitis
    7. Screening laboratory analyses showing any of the following results

      • Hemoglobin (Hb) level < 10 g/dL
      • Absolute neutrophil count (ANC) < 1,500 cells/μL
      • Platelet count < 70,000 cells/mm3
      • International normalized ratio (INR) > 2.0
      • Albumin (Alb)< 3.0 g/dL
      • Bilirubin (Bil) > 2.0 mg/dL
      • Alanine aminotransferase (ALT) > 10X upper limit of normal (ULN)
      • Aspartate aminotransferase (AST) > 10X upper limit of normal (ULN)
      • Serum alfa-fetoprotein (AFP) > 100 ng/mL
  • Presence of hepatocellular carcinoma (HCC) on imaging studies such as computed tomography (CT) scan or magnetic resonance imaging (MRI)
  • History of malignancy (except cutaneous melanoma) within 5 years at the screening
  • Organ transplantation other than cornea and hair (prior renal transplantation with graft failure not included)
  • Prior exposure to investigational agents for HCV (direct acting antiviral agents, host-targeting agents, or therapeutic vaccines)
  • Pregnancy
  • Unwilling to have contraception during the study period
  • Unwilling to provide informed consent

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): NCT03420300


Locations
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Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Far Eastern Memorial Hospital
Taipei county, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Chen-Hua Liu, MD, PhD National Taiwan University Hospital
  Study Documents (Full-Text)

Documents provided by National Taiwan University Hospital:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03420300    
Other Study ID Numbers: 201709053MIPC
First Posted: February 5, 2018    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Confidential of the individual participant data

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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 National Taiwan University Hospital:
Hepatitis C virus
Hemodialysis
Direct acting antiviral agent
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Elbasvir-grazoprevir drug combination
Antiviral Agents
Anti-Infective Agents