GP-renal trial

JRCT ID: jRCTs031200042

Registered date:01/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C infection
• Date of first enrollment: 21/01/2021
• Target sample size: 44
• Study type: Interventional
• Intervention(s): Glecaprevir/Pibrentasvir

Outcome(s)

Primary Outcome

Incident rate of drug-related adverse events (pruritus, headache, nausea, fatigue, elevated bilirubin, and elevated ALT)
For evaluation of adverse events, we use "Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Japanese version)"

Secondary Outcome

[Secondary outcomes of efficacy]
As secondary outcomes of efficacy, we evaluate the percentage of subjects achieving a 12-week sustained virologic response (SVR12), the percentages of subjects with on-treatment virologic failure, the percentages of subjects with post-treatment relapse, the percentage of subjects achieving a SVR4 and quality of life (QOL) score of subjects.
[Secondary outcomes of safety]
As secondary outcomes of safety, we evaluate the discontinuation rate due to adverse events. For evaluationof adverse events, we use "Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Japanese version)".

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects must meet all of the following criteria to be included in this study.
1)Subjects have plasma HCV-RNA load >= 3.0 log IU/mL at screening visit.
2)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.
3)Subjects have been receiving hemodialysis for renal impairment.
4)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.
5)Cirrhotic subjects only: Child-Pugh A classification at screening and no current or past clinical evidence of Child-Pugh B or C classification.
6)No current or past clinical history of liver decompensation including ascites, bleeding varices, or hepatic encephalopathy.
7)Male or female, at least 20 years of age at time of screening.
8)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.

Exclude criteria

Subjects who fall under any of the following criteria, will be excluded from the study.
1)Subjects with malignant tumors which could not be cured.
2)Requirement for and inability to safely discontinue the prohibited medications, such as atazanavir sulfate, atorvastatin and rifampicin.
3)Subjects with chronic hepatitis B who have not received nucleotide analog.
4)Gastrointestinal disorders which may affect drug absorption and pharmacokinetics.
5)Female who is pregnant, planning to become pregnant during the study or breastfeeding (In case of suspected pregnancy, pregnancy test should be conducted).
6)History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
7)Recent history of drug or health, psychological, social problems that could preclude adherence to the protocol.
8)Any condition that could impair safety of subjects or could preclude adherence to the protocol in the opinion of the investigator.

Related Information

• Primary Sponsor: Nakamura Masato
• Source(s) of Monetary Support: Chiba University Hospital