Trial Outcomes & Findings for Multi-Drug Desensitization Protocol for Heart Transplant Candidates (NCT NCT01556347)
NCT ID: NCT01556347
Last Updated: 2018-06-15
Results Overview
Percentage of highly sensitized heart transplant candidates, (patients with a CPRA greater than 50%), who have desensitization therapy, and then achieve a reduction in alloantibody such that their CPRA falls below 20%. For an individual patient, the outcome measure time frame is the one year of the Recovery Phase which begins after 218 days from the time that the patient begins the Induction Immunotherapy Phase, which is the same as the end of the Bortezomib Treatment Phase.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
365 days
Results posted on
2018-06-15
Participant Flow
The candidates for this study were recruited from the clinic of the Inland Northwest Heart Transplant and Mechanical Heart Program at Providence Sacred Heart Medical Center in Spokane, Washington. The Study received final IRB approval Jan. 4, 2013 after having received FDA approval.
The potential candidates had to be accepted heart transplant candidates who met a stringent list of inclusion and exclusion criteria to become study candidates.
Participant milestones
| Measure |
Highly Sensitized Heart Transplant Candidates
This was a Single Group Assignment Interventional Study to determine if a multi-drug regimen could be used to delete immunologic memory in order to reduce or eliminate alloreactive anti-HLA antibodies in highly sensitized heart transplant candidates. It was a non-randomized, open label, safety/efficacy (pilot) treatment study. It was hoped that if the calculated panel reactivity antibody (CPRA) was reduced to less than 20% via the protocol, then the patients could become functionally transplantable. There were three phases of the study, an Induction Immunotherapy Phase, a Bortezomib Treatment Phase, and a Recovery Phase. Both patients completed each of the three phases.
|
|---|---|
|
Induction Immunotherapy
STARTED
|
2
|
|
Induction Immunotherapy
COMPLETED
|
2
|
|
Induction Immunotherapy
NOT COMPLETED
|
0
|
|
Bortezomib Treatment Phase
STARTED
|
2
|
|
Bortezomib Treatment Phase
COMPLETED
|
2
|
|
Bortezomib Treatment Phase
NOT COMPLETED
|
0
|
|
Recovery Phase
STARTED
|
2
|
|
Recovery Phase
COMPLETED
|
2
|
|
Recovery Phase
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-Drug Desensitization Protocol for Heart Transplant Candidates
Baseline characteristics by cohort
| Measure |
Elimination of Immunologic Memory
n=2 Participants
A Multi-drug regimen is used to delete immunologic memory in order to reduce or eliminate alloreactive anti-HLA antibodies in highly sensitized heart transplant candidates.
Bortezomib, Thymoglobulin, (rATG), Rituximab, Gamimune N, (IVIG), Plasmapheresis (Multidrug Protocol): Bortezomib, Thymoglobulin, (rATG), Rituximab, Gamimune N, (IVIG), Plasmapheresis
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 365 daysPopulation: There were two patients entered into the study and therefore two patients analyzed.
Percentage of highly sensitized heart transplant candidates, (patients with a CPRA greater than 50%), who have desensitization therapy, and then achieve a reduction in alloantibody such that their CPRA falls below 20%. For an individual patient, the outcome measure time frame is the one year of the Recovery Phase which begins after 218 days from the time that the patient begins the Induction Immunotherapy Phase, which is the same as the end of the Bortezomib Treatment Phase.
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
Percentage of Patients With a Reduction in CPRA to Less Than 20%
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 365 daysPopulation: The two patients who were entered into the study were analyzed.
Percentage of patients, who are transplanted within one year of finishing the Bortezomib treatment phase.
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
Percentage of Patients Transplanted
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 583 daysPopulation: Two patients were entered into the study and both were analyzed
Percentage of study patients who experience a serious safety issue during the three phases of the study as measured by all cause mortality, serious adverse reactions and other adverse reactions.
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
n=2 Participants
The number of study patients with serious adverse events.
|
Other Adverse Events
n=2 Participants
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
Percentage of Patients Who Suffer Mortality, a Serious Adverse Event, or Other Adverse Event During the Study Period
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: 583 daysPopulation: There were two patients entered into the study and both were analyzed.
Percentage of patients who experience of grade 3 and above non-hematologic toxicities as measured by the incidence of hypersensitivity reaction, fever, nausea and vomiting or dehydration during the study period.
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
Percentage of Patients Who Experience Grade 3 and Above Non-Hematologic Toxicities
Hypersensitivity Reaction
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Patients Who Experience Grade 3 and Above Non-Hematologic Toxicities
Fever
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Patients Who Experience Grade 3 and Above Non-Hematologic Toxicities
Nausea and Vomiting
|
1 Participants
|
—
|
—
|
—
|
|
Percentage of Patients Who Experience Grade 3 and Above Non-Hematologic Toxicities
Dehydration
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 583 daysPopulation: The two patients entered into the study were analyzed.
The percentage of patients in the study who experience any grade of peripheral neuropathy during the study period
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
The Percentage of Patients Who Experience Any Grade of Peripheral Neuropathy
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 583 daysPopulation: The two patients who entered the study were evaluated.
Percentage of patients who experience cytomegalovirus (CMV), post-transplant lymphoproliferative disease (PTLD), or progressive multifocal leukoencephalopathy (PML) during the study period.
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
Percentage of Patients Who Experience CMV, PTLD, and PML
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 583 daysPopulation: The two patients who entered the study were evaluated
The percentage of study patients who experience infectious complications in either the respiratory or urinary tracts during the study period.
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
n=2 Participants
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
The Percentage of Patients Who Experience Either a Respiratory Tract Infection or a Urinary Tract Infection
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 583 daysPopulation: The two patients entered into the study were evaluated.
The percentage of study patients who experience an exacerbation of cardiac dysrhythmias and heart failure during the study period
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
n=2 Participants
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
The Percentage of Patients Who Experience Exacerbations Cardiac Dysrhythmias or Heart Failure
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 583 daysPopulation: The two patient who entered the study were evaluated
A Grade 4 hematologic toxicity includes a platelet count \< 25,000/mm3 or an absolute neutrophil count \< 500/mm3
Outcome measures
| Measure |
Highly Sensitized Heart Transplant Candidates
n=2 Participants
The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
|
Serious Adverse Events
The number of study patients with serious adverse events.
|
Other Adverse Events
The number of study patients who had adverse events other than serious.
|
Non-fatal Serious Cardiac Event
Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
|
|---|---|---|---|---|
|
Percentage of Patients With Grade 4 Hematologic Toxicities
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 730 daysPopulation: No study patient met the criteria for this measure since no patients were transplanted during the study period. The one patient who was eventually transplanted did not live to 6 months after the transplant.
The percentage of patients who experience antibody mediated rejection at 6 months and 1 year post transplant. The study period was 583 days, during which a patient was eligible for transplant during the last 365 days. If a patient was transplanted on day 583, then the patient is followed for one year after the transplant, then the total time to assess the two patients would have been a period of two years or 730 days. In fact, neither patient was transplanted within the study period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 730 daysPopulation: No patients met the criteria for this measure since the one patient eventually transplanted did not live long enough to develop donor specific antibodies.
Percentage of patients who are transplanted with the study period who then develop de novo or donor-specific alloantibody (DSA) within one year post-transplant. The patients would be eligible for transplant after day 218 in the study protocol and the study had 365 days in which to be transplanted. If a patient was transplant on day 583,( the last day of eligibility), and then followed for one year, then the outcome time frame would be a total of two years. No patient was transplanted within the study period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 730 daysPopulation: No patients were in this group
Percentage of patients who receive a transplant within the study period who are then DSA negative at 1 year following transplantation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 730 daysPopulation: No patients received a transplant during the study period. The one patient who was transplanted outside of the study period did not survive to 6 months.
The percentage of allografts transplanted during the study period that survive to 6 and 12 months post transplant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 730 daysPopulation: No patients met the criteria for this group. The one patient who received a transplant did not have the transplant during the study period, and she did not have signs of rejection at the time of her autopsy.
The percentage of allografts that have an acute rejection episode per the criteria of the International Society of Heart and Lung Transplantation (ISHLT) within one year of transplantation. Allografts implanted during the Recovery Phase are monitored for a year for acute rejection per the study protocol. An allograft potentially implanted on the last day of a patient's recovery period would still be monitored for a year, so the potential outcome measure time would be 730 days. Since no allografts were implanted during the recovery period, there are no results to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 583 daysPopulation: No patients met this criteria since no patient had a CPRA of less than 20%.
Proportion of patients who achieve a Calculated Panel Reactive Antibody test CPRA of \< 20%, but are not transplanted within the study period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 730 daysPopulation: No patients were transplanted within the study period so no patients could be analyzed for these potential outcomes
Percentage of study patients who receive transplants within the study period who then experience death, allograft loss, hospitalization due to infection, and non-fatal serious adverse cardiac event (defined as acute myocardial infarction, congestive heart failure, need for percutaneous cardiac intervention, coronary artery bypass grafting, cardiac defibrillator placement, cerebral vascular accident, peripheral vascular disease) within 1 year of transplantation.
Outcome measures
Outcome data not reported
Adverse Events
Study Treatment Group
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Treatment Group
n=2 participants at risk
All subjects will receive the study treatment. This is a non-randomized, open label study. The study treatment consists of an Induction phase with Thymoglobulin, Rituximab and Methylprednisolone, a Treatment phase with Bortezomib and a Recovery phase to follow-up and re-immunize and transplant the subject.
|
|---|---|
|
Immune system disorders
Hospitalized with Hypersensitivity
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Hospitalized with Fever
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Cardiac disorders
Hospitalized with LVAD Device Malfunction
|
50.0%
1/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Hospitalization for Nausea/Vomiting/Diarrhea
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Hospitalized with Dehydration
|
50.0%
1/2 • Number of events 4 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
Other adverse events
| Measure |
Study Treatment Group
n=2 participants at risk
All subjects will receive the study treatment. This is a non-randomized, open label study. The study treatment consists of an Induction phase with Thymoglobulin, Rituximab and Methylprednisolone, a Treatment phase with Bortezomib and a Recovery phase to follow-up and re-immunize and transplant the subject.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising-Abdominal
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Abdominal Distention
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Pain-Abdominal
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
2/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Musculoskeletal and connective tissue disorders
Pain-Back
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Eye disorders
Blurry Vision
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Cardiac disorders
Chest/Thorax NOS Pain
|
50.0%
1/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Nervous system disorders
Confusion
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Decreased Bicarb
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Ear and labyrinth disorders
Decreased Hearing
|
100.0%
2/2 • Number of events 3 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Decreased Hemoglobin
|
100.0%
2/2 • Number of events 4 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Decreased Phosphate
|
100.0%
2/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Number of events 4 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Nervous system disorders
Dizziness
|
100.0%
2/2 • Number of events 4 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnes
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Elevated Uric Acid
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 3 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Endocrine disorders
Hot Flashes
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Immune system disorders
Hyperreaction to IVIG
|
100.0%
2/2 • Number of events 3 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Cardiac disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Hypocalcemia
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Hypoglycemia
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Hypokalemia
|
100.0%
2/2 • Number of events 4 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Hypomagnesemia
|
100.0%
2/2 • Number of events 5 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Cardiac disorders
Hypotension
|
100.0%
2/2 • Number of events 6 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Renal and urinary disorders
Incontinence
|
100.0%
2/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Investigations
Increased Creatinine
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Infections and infestations
Infection-Oral Cavity (Thrush)
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity/Limb Pain
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps/pain
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 7 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Nervous system disorders
Neuralgia/Peripheral Nerve Pain
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Immune system disorders
Neutropenia
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Renal and urinary disorders
Painful Urination
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Blood and lymphatic system disorders
Peripheral Edema
|
50.0%
1/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
2/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Immune system disorders
Serum Sickness
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Stomach Ulcer
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Nervous system disorders
Syncope
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Throat Pain
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Ear and labyrinth disorders
Tinnitus
|
100.0%
2/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Musculoskeletal and connective tissue disorders
Upper Extremity/Limb Pain
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Infections and infestations
Upper Respiratory Infection
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Infections and infestations
Urinary Tract Infection
|
50.0%
1/2 • Number of events 6 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Cardiac disorders
Ventricular Arrhythmias
|
100.0%
2/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
2/2 • Number of events 4 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Musculoskeletal and connective tissue disorders
Difficulty Walking
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
100.0%
2/2 • Number of events 2 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Musculoskeletal and connective tissue disorders
Weakness of left hand
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
General disorders
Weight Loss
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
|
Injury, poisoning and procedural complications
Bleeding from LVAD driveline site
|
50.0%
1/2 • Number of events 1 • Adverse events will be collected from the initiation of study treatment through all three phases of the study the duration of which is 583 days. A patient could be transplanted on the last day of the recovery phase,(day 583), would then be followed for a year after the transplant for a total of 948 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place