臨床研究等提出・公開システム

Safety and efficacy of glecaprevir and pibrentasvir in patients with hepatitis C virus infection and end-stage renal disease undergoing dialysis; a prostective study

GP-renal trial

1

61 years old, Male, Younger cohort, Chronic hepatitis

The first case was registered on 21-Jan-2021. No further registrations.

Not applicable

No analysis was performed because the number of cases was not reached that required for analysis.

The study was terminated on 30-Apr-2022 because the planned number of cases was not reached at the expiration of the case enrollment period and there was no prospect of enrolling more cases in the future.

Oct. 31, 2022

No

Not applicable

https://jrct.niph.go.jp/latest-detail/jRCTs031200042

Nakamura Masato

Chiba University

1-8-1, Inohana, Chuo-ku, Chiba city, Chiba, Japan

nakamura-ma@chiba-u.jp

Nakamura Masato

Chiba University

1-8-1, Inohana, Chuo-ku, Chiba city, Chiba, Japan

+81-43-222-7171

nakamura-ma@chiba-u.jp

Complete

June. 01, 2020

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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.

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.

Both

Chronic hepatitis C infection

Glecaprevir/Pibrentasvir

Anti-viral therapy

Direct-acting anti-viral agent

D019698

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 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)".

+81-43-226-2616

May. 20, 2020

none