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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.
This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the inclusion criteria and report symptoms of gastrointestinal side-effects while taking Cellcept will be switched to Myfortic. All 20 patients will be followed closely over a period of 6 months following enrollment. Concomitant immunosuppressive therapy will continue in all patients per standard treatment protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteric-coated Mycophenolate Sodium (Myfortic) | Other | 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Sodium | Drug | 1440mg/day (720mg by mouth, twice a day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| GI Tolerability as Measured by GSRS | Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale) GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. | Number of biopsy proven acute rejection, graft loss, and death due to rejection. Number of rejection episodes where rejection is defined as Grade 1B or higher on myocardial biopsy as measured by the 1990 Grading System of the International Society of Heart and Lung Transplantation for Acute Cellular Rejection. Grading system has:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernst Schwarz, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars- Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enteric-coated Mycophenolate Sodium (Myfortic) | 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enteric-coated Mycophenolate Sodium (Myfortic) | 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | GI Tolerability as Measured by GSRS | Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale) GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enteric-coated Mycophenolate Sodium (Myfortic) | Enteric-coated Mycophenolate Sodium (Myfortic) 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Non-systematic Assessment |
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This is a small sample size study and 3 participants did not finish the 6 month visit
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ernst Schwarz, MD, PhD | Cedars-Sinai Medical Center | (310) 840-7089 | Ernst.Schwarz@cshs.org |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 6 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. | Number of biopsy proven acute rejection, graft loss, and death due to rejection. Number of rejection episodes where rejection is defined as Grade 1B or higher on myocardial biopsy as measured by the 1990 Grading System of the International Society of Heart and Lung Transplantation for Acute Cellular Rejection. Grading system has:
| Posted | Count of Units | myocardial biopsies | 6 months | myocardial biopsies | myocardial biopsies |
|
|
|
| 1 |
| 11 |
| 8 |
| 11 |
| 0 |
| 11 |
| Heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Heart re-transplant | Cardiac disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hypovolemia | Cardiac disorders | Non-systematic Assessment |
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| Steroid induced myopathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| GI Bleeding | Gastrointestinal disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |