jRCTs031200042CompletedNot Applicable
Safety and efficacy of glecaprevir and pibrentasvir in patients with hepatitis C virus infection and end-stage renal disease undergoing dialysis; a prostective study
Not provided0 sites44 target enrollmentStarted: January 21, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Primary Endpoint
- Incident rate of drug-related adverse events
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Subjects must meet all of the following criteria to be included in this study.
- •Subjects have plasma HCV-RNA load >= 3.0 log IU/mL at screening visit.
- •Chronic HCV infection defined as following: Positive for anti-HCV antibody (Ab), HCV-RNA, a liver biopsy consistent with chronic HCV infection, or abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.
- •Subjects have been receiving hemodialysis for renal impairment.
- •Subjects must be documented as cirrhotic or non-cirrhotic at any time previously at screening, defined as meeting one of the following criteria:
- •[Non-cirrhotics]
- •a) A liver biopsy within 24 months prior to or during screening demonstrating the absence of cirrhosis.
- •b) A Fibroscan score of <12.5 kPa within 6 months of screening or during the screening period and no evidence of cirrhosis on any imaging and no comorbidity caused by cirrhosis.
- •[Cirrhotics]
- •a) Histologic diagnosis of cirrhosis on a previous liver biopsy.
- •b) Previous Fibroscan score >= 12.5 kPa.
- •c) With evidence of cirrhosis on any imaging or comorbidity caused by cirrhosis.
- •Cirrhotic subjects only: Child-Pugh A classification at screening and no current or past clinical evidence of Child-Pugh B or C classification.
- •No current or past clinical history of liver decompensation including ascites, bleeding varices, or hepatic encephalopathy.
- •Male or female, at least 20 years of age at time of screening.
- •Subjects must understand all other protocol requirements and voluntarily sign and date an informed consent form prior to the initiation of any screening or study-specific procedures.
Exclusion Criteria
- •Subjects who fall under any of the following criteria, will be excluded from the study.
- •Subjects with malignant tumors which could not be cured.
- •Requirement for and inability to safely discontinue the prohibited medications, such as atazanavir sulfate, atorvastatin and rifampicin.
- •Subjects with chronic hepatitis B who have not received nucleotide analog.
- •Gastrointestinal disorders which may affect drug absorption and pharmacokinetics.
- •Female who is pregnant, planning to become pregnant during the study or breastfeeding (In case of suspected pregnancy, pregnancy test should be conducted).
- •History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
- •Recent history of drug or health, psychological, social problems that could preclude adherence to the protocol.
- •Any condition that could impair safety of subjects or could preclude adherence to the protocol in the opinion of the investigator.
Outcomes
Primary Outcomes
Incident rate of drug-related adverse events
For evaluation of adverse events, we use "Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Japanese version)" Adverse events include: - pruritus - headache - nausea - fatigue - elevated bilirubin - elevated ALT
Secondary Outcomes
- 12-week sustained virologic response (SVR12)(12 weeks)
- on-treatment virologic failure
- post-treatment relapse
- SVR4(4 weeks)
- quality of life (QOL) score
- discontinuation rate due to adverse events
- Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Japanese version)
Investigators
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