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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00619398 |
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: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
---|---|
1: Active Comparator |
Drug: Prograf
Oral
|
2: Experimental |
Drug: FK506MR capsule
Oral
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Beijing, China | |
Shanghai, China | |
Tianjing, China | |
China, Guangdong | |
Guangzhou, Guangdong, China | |
China, Liaoning | |
Shenyang, Liaoning, China | |
China, Zheijiang | |
Hangzhou, Zheijiang, China |
Study Chair: | Central Contact | Astellas Pharma Inc |
Responsible Party: | Astellas Pharma Inc. ( Director ) |
Study ID Numbers: | MR4LTxCN02 |
Study First Received: | January 23, 2008 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00619398 History of Changes |
Health Authority: | China: State Food and Drug Administration |
FK506 tacrolimus prograf Liver transplantation |
Immunologic Factors Tacrolimus Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Tacrolimus Immunosuppressive Agents Pharmacologic Actions |