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This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMF, CsA, Corticosteroids | Experimental | Participants received mycophenolate mofetil (MMF) 1.0 grams (g), orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of cyclosporine A (CsA) 4 to 6 milligrams per kilogram (mg/kg) within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil (MMF) | Drug | 1.0 g PO BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week | Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis. | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 | |
| Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100029 | China | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA) | Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population: all enrolled participants who recieved at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | MMF + CsA | Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week | Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
All enrolled participants who received at least 1 dose of study drug were included in the safety analysis set.
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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 | MMF + CsA | Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple organ failure | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D016572 | Cyclosporine |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| cyclosporine A (CsA) | Drug | Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL |
|
| corticosteroids | Drug | As per the practice of each participating center |
|
| Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Fuzhou |
| 350001 |
| China |
| Shanghai | 200032 | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center. |
|
|
| Secondary | Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation | ITT population | Posted | Number | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation | ITT population | Posted | Number | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation | ITT population | Posted | Number | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment | ITT population | Posted | Number | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment | ITT population | Posted | Number | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment | ITT population | Posted | Number | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment | ITT population | Posted | Number | percentage of participants | Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| 2 |
| 36 |
| 36 |
| 36 |
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Wound complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Impaired renal function | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Dysphoria | Psychiatric disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Impaired healing | General disorders | Non-systematic Assessment |
|
| Elevated blood sugar | Investigations | Non-systematic Assessment |
|
| Elevated blood lipids | Investigations | Non-systematic Assessment |
|
| Elevated serum creatinine | Investigations | Non-systematic Assessment |
|
| Elevated alanine aminotransferase | Investigations | Non-systematic Assessment |
|
| Abnormal liver function tests | Investigations | Non-systematic Assessment |
|
| Elevated serum bilirubin | Investigations | Non-systematic Assessment |
|
| Leukocytosis | Investigations | Non-systematic Assessment |
|
| Elevated aspartate aminotransferase | Investigations | Non-systematic Assessment |
|
| High blood pressure | Investigations | Non-systematic Assessment |
|
| Dyslipidemia | Investigations | Non-systematic Assessment |
|
| Low blood pressure | Investigations | Non-systematic Assessment |
|
| Increased platelet count | Investigations | Non-systematic Assessment |
|
| Decreased serum glucose | Investigations | Non-systematic Assessment |
|
| Increased serum albumin | Investigations | Non-systematic Assessment |
|
| Increased heart rate | Investigations | Non-systematic Assessment |
|
| Neutrophilic granulocytosis | Investigations | Non-systematic Assessment |
|
| Elevated urea | Investigations | Non-systematic Assessment |
|
| Positive anti hepatitis B antigen | Investigations | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoproteinemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Premature beat | Cardiac disorders | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oral ulcers | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Wound bleeding | Vascular disorders | Non-systematic Assessment |
|
| Thrombus | Vascular disorders | Non-systematic Assessment |
|
| Perivenular inflammation | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |