Prediction of the pharmacokinetics and adverse events of paritaprevir in patients with hepatitis C virus by magnetic resonance imaging

Not Applicable

• Conditions: Type C chronic hepatitis or type C liver cirrhosis

• Registration Number: JPRN-UMIN000022587
• Lead Sponsor: Juntendo University Nerima Hospital Department of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-06
• Study Completion: 2017-10-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Y93 NS5A polymorphism (pretreatment resistance-associated variants) in the genotype 1b patients 2) Co-infection with hepatitis B or HIV 3) Evidence of viable hepatocellular carcinoma 4) Child-Pugh score greater than 7 5) Concurrent use of moderate to strong inducers of CYP3A and strong inducers of CYP2C8 reduce efficacy 6) Hypersensitivity to Gd-EOB-DTPA 7) Estimated glomerular filtration rate under 40ml/min/1.73m2

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To clarify the relationship between the pretreatment enhancement effect of Gd-EOB-DTPA MRI and the plasma paritaprevir concentration determined 7 days after its administration.

Secondary Outcome Measures

Name	Time	Method
To clarify the relationship among enhancement effect of Gd-EOB-DTPA,hepatic function, gene polymorphisms of hepatic transporter and hyperbilirubinemia during treatment.