Trials / Unknown
UnknownNCT03216447
A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant
A Prospective, Multi-center, Open-labeled, Randomized Clinical Trial of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant Recipients to Compare QD Early Conversion and BID Tacrolimus Formulation.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Chang Gung Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A study of patient adherence and convenience to immunosuppressive agents in newly liver transplant recipients - a prospective, multi-center, open-labeled, randomized clinical trial for comparison between once-daily early conversion and twice-daily tacrolimus formulation.
Detailed description
This is prospective, multi-center, open-labeled, randomized study to investigate adherence of administration of once-daily tacrolimus formulation (Advagraf®) in newly Taiwanese (Chinese) liver transplant patients. The procedure of liver transplantation will follow the site-specific procedure. Each subject will be randomized on postoperative day 15 (POD15; defined Day 14 +/- 1)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Advagraf | Tacrolimus prolonged-release hard capsules (QD) |
| DRUG | Prograf | Tacolimus capsules (q12h) |
Timeline
- Start date
- 2017-11-23
- Primary completion
- 2023-08-31
- Completion
- 2025-09-30
- First posted
- 2017-07-13
- Last updated
- 2020-06-05
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03216447. Inclusion in this directory is not an endorsement.