CLINICAL TRIALS PROFILE FOR MYFORTIC
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505(b)(2) Clinical Trials for Myfortic
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT00374803 ↗ | Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal | Completed | Novartis | Phase 4 | 2006-04-01 | To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin. |
| New Formulation | NCT00374803 ↗ | Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal | Completed | University of Cincinnati | Phase 4 | 2006-04-01 | To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin. |
| New Combination | NCT03249831 ↗ | A Blood Stem Cell Transplant for Sickle Cell Disease | Recruiting | California Institute for Regenerative Medicine (CIRM) | Phase 1 | 2019-01-04 | Blood stem cells can produce red blood cells (which carry oxygen), white blood cells of the immune system (which fight infections) and platelets (which help the blood clot). Patients with sickle cell disease produce abnormal red blood cells. A blood stem cell transplant from a donor is a treatment option for patients with severe sickle cell disease. The donor can be healthy or have the sickle cell trait. The blood stem cell transplant will be given to the patient as an intravenous infusion (IV). The donor blood stem cells will then make normal red blood cells - as well as other types of blood cells - in the patient. When blood cells from two people co-exist in the patient, this is called mixed chimerism. Most children are successfully treated with blood stem cells from a sibling (brother/sister) who completely shares their tissue type (full-matched donor). However, transplant is not an option for patients who (1) have serious medical problems, and/or (2) do not have a full-matched donor. Most patients will have a relative who shares half of their tissue type (e.g. parent, child, and brother/sister) and can be a donor (half-matched or haploidentical donor). Adult patients with severe sickle cell disease were successfully treated with a half-matched transplant in a clinical study. Researchers would like to make half-matched transplant an option for more patients by (1) improving transplant success and (2) reducing transplanted-related complications. This research transplant is being tested in this Pilot study for the first time. It is different from a standard transplant because: 1. Half-matched related donors will be used, and 2. A new combination of drugs (chemotherapy) that does not completely wipe out the bone marrow cells (non-myeloablative treatment) will be used to prepare the patient for transplant, and 3. Most of the donor CD4+ T cells (a type of immune cells) will be removed (depleted) before giving the blood stem cell transplant to the patient to improve transplant outcomes. It is hoped that the research transplant: 1. Will reverse sickle cell disease and improve patient quality of life, 2. Will reduce side effects and help the patient recover faster from the transplant, 3. Help the patient keep the transplant longer and 4. Reduce serious transplant-related complications. |
| New Combination | NCT03249831 ↗ | A Blood Stem Cell Transplant for Sickle Cell Disease | Recruiting | City of Hope Medical Center | Phase 1 | 2019-01-04 | Blood stem cells can produce red blood cells (which carry oxygen), white blood cells of the immune system (which fight infections) and platelets (which help the blood clot). Patients with sickle cell disease produce abnormal red blood cells. A blood stem cell transplant from a donor is a treatment option for patients with severe sickle cell disease. The donor can be healthy or have the sickle cell trait. The blood stem cell transplant will be given to the patient as an intravenous infusion (IV). The donor blood stem cells will then make normal red blood cells - as well as other types of blood cells - in the patient. When blood cells from two people co-exist in the patient, this is called mixed chimerism. Most children are successfully treated with blood stem cells from a sibling (brother/sister) who completely shares their tissue type (full-matched donor). However, transplant is not an option for patients who (1) have serious medical problems, and/or (2) do not have a full-matched donor. Most patients will have a relative who shares half of their tissue type (e.g. parent, child, and brother/sister) and can be a donor (half-matched or haploidentical donor). Adult patients with severe sickle cell disease were successfully treated with a half-matched transplant in a clinical study. Researchers would like to make half-matched transplant an option for more patients by (1) improving transplant success and (2) reducing transplanted-related complications. This research transplant is being tested in this Pilot study for the first time. It is different from a standard transplant because: 1. Half-matched related donors will be used, and 2. A new combination of drugs (chemotherapy) that does not completely wipe out the bone marrow cells (non-myeloablative treatment) will be used to prepare the patient for transplant, and 3. Most of the donor CD4+ T cells (a type of immune cells) will be removed (depleted) before giving the blood stem cell transplant to the patient to improve transplant outcomes. It is hoped that the research transplant: 1. Will reverse sickle cell disease and improve patient quality of life, 2. Will reduce side effects and help the patient recover faster from the transplant, 3. Help the patient keep the transplant longer and 4. Reduce serious transplant-related complications. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Myfortic
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00101738 ↗ | Freedom Study: Myfortic in Kidney Transplant Patients | Completed | Novartis Pharmaceuticals | Phase 3 | 2003-03-01 | The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients. |
| NCT00149968 ↗ | Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife) | Completed | Novartis | Phase 4 | 2005-04-01 | The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment. |
| NCT00154310 ↗ | Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients | Completed | Novartis | Phase 4 | 2005-06-01 | The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function. |
| NCT00167492 ↗ | Enteric Coated Myfortic for Liver Transplant Recipients | Withdrawn | Novartis | Phase 4 | 2005-09-01 | The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea. |
| NCT00167492 ↗ | Enteric Coated Myfortic for Liver Transplant Recipients | Withdrawn | The University of Texas Health Science Center, Houston | Phase 4 | 2005-09-01 | The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea. |
| NCT00251004 ↗ | Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients | Completed | Novartis | Phase 3 | 2005-10-01 | The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant. |
| NCT00267150 ↗ | Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants | Completed | Novartis Pharmaceuticals | Phase 3 | 2005-11-01 | Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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