Prediction of the pharmacokinetics and adverse events of glecaprevir/pibrentasvir in patients with hepatitis C virus by gadoxetic acid enhanced magnetic resonance imaging

Prediction of the pharmacokinetics and adverse events of glecaprevir/pibrentasvir in patients with hepatitis C virus by gadoxetic acid enhanced magnetic resonance imaging - Prediction of the PKs and AEs of GLE/PIB by EOB-MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034251

Enrollment

Registered

2018-09-25

Start date

2018-09-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type C chronic hepatitis or type C liver cirrhosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) chronic hepatitis C or compensated liver cirrhosis C patients using glecaprevir and pibrentasvir

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to Gd-EOB-DTPA 2) Estimated glomerular filtration rate under 40ml/min/1.73m2

Design outcomes

Primary

Measure	Time frame
To clarify the relationship between the pretreatment enhancement effect of Gd-EOB-DTPA MRI and the plasma glecaprevir concentration determined 7 days after its administration	—

Secondary

Measure	Time frame
To clarify the relationship between enhancement effect of Gd-EOB-DTPA MRI and development of hyperbilirubinemia during treatment.	—

Countries

Japan

Contacts

Public ContactHironao Okubo

Juntendo University Nerima Hospital Department of gastroenterology

drokubo@juntendo-nerima.jp+81-3-5923-3111

Outcome results