Prediction of the pharmacokinetics of asunaprevir in patients with hepatitis C virus by gadoxetic-acid-enhanced-magnetic resonance imaging
Not Applicable
Completed
- Conditions
- Type C chronic hepatitis or type C liver cirrhosis
- Registration Number
- JPRN-UMIN000016667
- Lead Sponsor
- Juntendo University Nerima Hospital Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The relationship between hepatic enhancement with gadoxetic acid-enhanced MRI and the blood concentration of asunaprevir
- Secondary Outcome Measures
Name Time Method The relationships among blood concentration of ASV, hepatic function, polymorphism of hepatic transporter, and adverse events.