Trials / Unknown
UnknownNCT02882113
Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion
Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion From Tacrolimus (Bid) to Advagraf® (qd) in Stable Liver Transplant Recipients
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated clinical trial to assess the influence of CYP3A5 polymorphism on liver function abnormality and the trough level change after conversion to Advagraf® in liver transplant recipients.
Detailed description
All subjects who are liver transplant recipients taking Tacrolimus bid and adaptable to be registered for the study will be classified by expressive or non-expressive CYP3A5 polymorphism genotype and Advagraf® will be administered same dose as Tacrolimus bid der day in 24 weeks. All subjects should check whether being registered in the hospital based on CYP3A5 polymorphism genotype during screening visit. Registered subjects will visit seven times to the hospital during the study which includes screening visit and adverse reaction, acute rejection, and trough level will be tested during this period. Subjects who are additionally agreed for PK study will be hospitalized with the state of Tacrolimus bid therapy one day ago before taking IP. On the first day of hospitalization, his/her blood will be collected. At week 1 (plus seven days) after conversion to Advagraf®, his/her blood will be collected for PK analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Advagraf | same dose as Tacrolimus bid der day in 24 weeks |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2018-08-01
- Completion
- 2018-12-01
- First posted
- 2016-08-29
- Last updated
- 2016-08-31
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02882113. Inclusion in this directory is not an endorsement.