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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022587

Enrollment

Registered

2016-06-06

Start date

2016-06-06

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: Genotype 1b chronic hepatitis C or compensated liver cirrhosis C patients using ombitasvir, paritaprevir and ritonavir. Genotype 2a chronic hepatitis C patients using ombitasvir, paritaprevir and ritonavir with ribavirin.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To clarify the relationship among enhancement effect of Gd-EOB-DTPA,hepatic function, gene polymorphisms of hepatic transporter and 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