Status:
COMPLETED
EBR/GZR for HCV-1b Patients Receiving Hemodialysis
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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), proba...
Detailed Description
Hepatitis C virus (HCV) infection remains a major co-morbidity in hemodialysis patients. The incidence and prevalence rates of HCV infection in hemodialysis patients are much higher than those in the ...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03420300
Start Date
June 5 2018
End Date
February 3 2020
Last Update
March 11 2020
Active Locations (6)
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1
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
2
China Medical University Hospital
Taichung, Taiwan
3
Taichung Veterans General Hospital
Taichung, Taiwan
4
National Taiwan University Hospital
Taipei, Taiwan