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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00619398 |
Purpose
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Transplantation |
Drug: Prograf Drug: FK506MR capsule |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients and a Pharmacokinetics Study |
| Enrollment: | 172 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Prograf
Oral
Other Names:
|
| Experimental: 2 |
Drug: FK506MR capsule
Oral
Other Names:
|
A multicentre, randomized, open label, two parallel group study The patients will be randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12 weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China, Beijing | |
| Beijing, Beijing, China | |
| China, Guangdong | |
| Guangzhou, Guangdong, China | |
| China, Liaoning | |
| Shenyang, Liaoning, China | |
| China, Shanghai | |
| Shanghai, Shanghai, China | |
| China, Tianjing | |
| Tianjing, Tianjing, China | |
| China, Zheijiang | |
| Hangzhou, Zheijiang, China | |
| Study Chair: | Central Contact | Astellas Pharma Inc |
More Information
| Responsible Party: | Director, Astellas Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00619398 History of Changes |
| Other Study ID Numbers: | MR4LTxCN02 |
| Study First Received: | January 23, 2008 |
| Last Updated: | March 10, 2009 |
| Health Authority: | China: State Food and Drug Administration |
|
FK506 tacrolimus prograf Liver transplantation |
|
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |