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EBR/GZR for HCV-1b Patients Receiving Hemodialysis

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ClinicalTrials.gov Identifier: NCT03420300
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : August 7, 2018
Sponsor:
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EBR/GZR
Elbasvir/grazoiprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks
Drug: EBR/GZR
Elbasvir/grazoiprevir (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) [ Time Frame: 24 weeks ]
    Undetectable serum HCV RNA 12 weeks off therapy (treatment period 12 weeks)


Secondary Outcome Measures :
  1. Treatment-emergent adverse event (AE)-related withdrawal rate [ Time Frame: 12 weeks ]
    Treatment-emergent adverse event (AE)-related withdrawal rate

  2. Sustained virologic response (SVR24) [ Time Frame: 36 weeks ]
    Undetectable serum HCV RNA 24 weeks off therapy (treatment period 12 weeks)

  3. Rapid virologic response (RVR) [ Time Frame: 4 weeks ]
    Undetectable serum HCV RNA at week 4 of treatment

  4. End-of-treatment virological response (EOTVR) [ Time Frame: 12 weeks ]
    Undetectable serum HCV RNA at week 12 of treatment



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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


Contacts
Contact: Chen-Hua Liu, MD, PhD +886-223123456 ext 63572 jacque_liu@mail2000.com.tw
Contact: Jia-Horng Kao, MD, PhD +886-223123456 ext 67307 kaojh@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital, Yun-Lin Branch Recruiting
Douliu, Taiwan
Contact: Yu-Ren Fang, MD         
Sub-Investigator: Chen-Hua Liu, MD, PhD         
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Cheng-Yuan Peng, MD, PhD         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Contact: Sheng-Shun Yang, MD, PhD         
Far Eastern Memorial Hospital Recruiting
Taipei county, Taiwan
Contact: Cheng-Kuan Lin, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chen-Hua Liu, MD, PhD    +886-223123456 ext 63572    jacque_liu@mail2000.com.tw   
Sub-Investigator: Jia-Horng Kao, MD, PhD         
Sub-Investigator: Pei-Jer Chen, MD, PhD         
Sub-Investigator: Chun-Jen Liu, MD, PhD         
Sub-Investigator: Ding-Shinn Chen, MD         
Sub-Investigator: Hung-Chih Yang, MD, PhD         
Taipei Medical University Recruiting
Taipei, Taiwan
Contact: Wei-Yu Kao, MD         
Sub-Investigator: Chun-Chao Chang, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Chen-Hua Liu, MD, PhD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03420300     History of Changes
Other Study ID Numbers: 201709053MIPC
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Confidential of the individual participant data

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:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections