Prediction of the pharmacokinetics of asunaprevir in patients with hepatitis C virus by gadoxetic-acid-enhanced-magnetic resonance imaging

Prediction of the pharmacokinetics of asunaprevir in patients with hepatitis C virus by gadoxetic-acid-enhanced-magnetic resonance imaging - Pharmacokinetics of asunaprevir by MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016667

Enrollment

Registered

2015-03-02

Start date

2015-03-02

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: Hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir

Exclusion criteria

Exclusion criteria: 1) Y-93H NS5A polymorphism (pretreatment resistance-associated variants) 2) Co-infection with hepatitis B or HIV 3) Previous exposure to inhibitors of NS5A or NS3A protease 4) Evidence of viable hepatocellular carcinoma 5) Alanine aminotransferase of more than five times the upper limit of the normal range 6) Child-Pugh score greater than 7 7) Patients taking the following drugs:rifampicin,rifabutin,phenytoin, carbamazepine,phenobarbital,systemic administration of dexamethasone, St Johns wort 8) Hypersensitivity to gadoxetic acid 9) Estimated glomerular filtration rate under 40 mL/min/1.73m2

Design outcomes

Primary

Measure	Time frame
The relationship between hepatic enhancement with gadoxetic acid-enhanced MRI and the blood concentration of asunaprevir	—

Secondary

Measure	Time frame
The relationships among blood concentration of ASV, hepatic function, polymorphism of hepatic transporter, and adverse events.	—

Countries

Japan

Contacts

Public ContactHironao Okubo

Juntendo University Nerima Hospital Department of Gastroenterology

drokubo@juntendo-nerima.jp03-5923-3111

Outcome results