Biliary Concentration of Tacrolimus Clinical Trial
— STABILEOfficial title:
Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
| Verified date | September 2017 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | April 7, 2017 |
| Est. primary completion date | April 7, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients (> 18 years) of both sexes, - Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease, - Not having expressed their opposition to participation in the study Exclusion Criteria: - Bilio-enteric anastomosis, - Associated transplantation of another organ - Contraindications to TCR administration - Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre hospitalier universitaire de Rennes | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC | during the first 7 days after its initiation |