EBR/GZR for HCV-1b Patients Receiving Hemodialysis

NCT03420300 | Completed Phase 4 Results

• 1 other identifier: 201709053MIPC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatitis C

Keywords

Hepatitis C virus; Hemodialysis; Direct acting antiviral agent

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response (SVR12) Rate

  Proportion of patients who had undetectable serum HCV RNA 12 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)

  24 weeks

Secondary Outcomes (5)

• Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate

  12 weeks

• Sustained Virologic Response (SVR24) Rate

  36 weeks

• Rapid Virologic Response (RVR) Rate

  4 weeks

• End-of-treatment Virological Response (EOTVR) Rate

  12 weeks

• Week 12 Virologic Response (W12VR)

  12 weeks

Study Arms (1)

EBR/GZR

EXPERIMENTAL

Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks

Drug: EBR/GZR

Interventions

EBR/GZR DRUG

Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks

Also known as: Zepatier

EBR/GZR

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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

You may not qualify if:

• 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
• Hemochromatosis
• Alfa-1 antitrypsin deficiency
• Wilson's disease
• Autoimmune hepatitis
• Alcoholic liver disease
• Drug-induced hepatitis
• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Medical University

Taipei, Taiwan

Location

Far Eastern Memorial Hospital

Taipei County, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

This study enrolled the tolerability and efficacy in East-Asian patients, where the results may not be generalized to other races.

Results Point of Contact

• Title: Dr. Chen-Hua Liu
• Organization: National Taiwan University Hospital

jacque_liu@mail2000.com.tw

+886-223123456

Study Officials

• Chen-Hua Liu, MD, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 5, 2018
• Study Start: June 5, 2018
• Primary Completion: November 2, 2019
• Study Completion: February 3, 2020
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)