Trial Outcomes & Findings for Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (NCT NCT02464878)

Last Updated: 2023-12-22

Results Overview

Insulin Independence examined 75 days after 1st infusion; subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window at Day 75 (Day 70-80) and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window (Day 63-87); 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; (6) at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Day 75

Results posted on

2023-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Main Study Treatment Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 75

Population: Due to reduced enrollment in study, unable to make statistically appropriate comparison between subjects receiving GLASSIA and Control CIT06 subjects from NCT00468117. Information provided is pertinent to the two subjects enrolled based on descriptions of Primary and Secondary Outcomes

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. Ability to titrate of insulin therapy for at least 1 week	0 Participants
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. Documented HbA1c, fasting serum glucose level, MMTT, & 7 days blood sugar/insulin readings	2 Participants
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. HbA1c ≤ 6.5% or a ≥ 2.5% decrease from baseline (within 91 days prior to transplant)	2 Participants
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. Fasting capillary glucose level should not exceed 140 mg/dL more than 3 x in 7 consecutive days	1 Participants
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. Post-prandial serum glucose ≤ 180 mg/dL at 90 minutes during the MMTT	1 Participants
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. Fasting serum glucose level ≤ 126 mg/dL	1 Participants
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets. At least one MMTT fasting or stimulated c-peptide ≥ 0.5 ng/mL	2 Participants

SECONDARY outcome

Timeframe: 1 year after the first islet infusion, 1 year after the last islet infusion, 2 years after the first islet infusion, 2 years after the last islet infusion

Subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window of time frame, noted below, and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window; 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; 6. at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions 1 yr after 1st infusion	2 Participants
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions 1 yr after last infusion	1 Participants
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions 2 yrs after 1st infusion	1 Participants
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions 2 yrs after last infusion	1 Participants

SECONDARY outcome

Timeframe: From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.

Number of subjects with both an HbA1c \</= 6.5% and no severe hypoglycemic events at specified timepoints; data utilized for measure were HbA1c levels and number of severe hypoglycemic events.

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Proportion of GLASSIA Treated Versus CIT06 Control Subjects With Both an HbA1c ≤ 6.5% AND an Absence of Severe Hypoglycemic Events Day 28-365 after 1st infusion	2 Participants
The Proportion of GLASSIA Treated Versus CIT06 Control Subjects With Both an HbA1c ≤ 6.5% AND an Absence of Severe Hypoglycemic Events Day 28-730 after 1st infusion	1 Participants

SECONDARY outcome

Timeframe: From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.

Subjects with an HbA1c \<7.0% and free of severe hypoglycemic events at specified timepoints; data utilized were HbA1c levels and number/absence of severe hypoglycemic events

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Proportion of GLASSIA Treated Versus Control Subjects With Both an HbA1c < 7.0% AND Free of Severe Hypoglycemic Events Day 28-365 after 1st infusion	2 Participants
The Proportion of GLASSIA Treated Versus Control Subjects With Both an HbA1c < 7.0% AND Free of Severe Hypoglycemic Events Day 28-730 after 1st infusion	1 Participants

SECONDARY outcome

Timeframe: From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.

Subjects with a reduction in HbA1c of 1 point and no severe hypoglycemia at specific timepoints. Data utilized were HbA1c numbers at specified timepoints and absence of any severe hypoglycemic events

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects A Reduction in HbA1c of 1 Point AND an Absence of Severe Hypoglycemia Day 28-365 after 1st infusion	1 Participants
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects A Reduction in HbA1c of 1 Point AND an Absence of Severe Hypoglycemia Day 28-730 after 1st infusion	1 Participants

SECONDARY outcome

Timeframe: 1 year and 2 years after the first islet transplant

Clarke Score is a 7 question patient report of hypoglycemia awareness. Answers provide a rating of either A (aware) or R (reduced). Four or more R ratings suggest impaired hypoglycaemia awareness; \< or equal to 2 = normal awareness, 3=borderline. A higher Clarke Score indicates reduced awarness.

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects Year 1 after 1st Infusion : Clarke Score improved from Baseline	1 Participants
The Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects Year 1 after 1st Infusion : Clarke Score without improvement from Baseline	1 Participants
The Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects Year 2 after 1st Infusion : Clarke Score improved from Baseline	1 Participants
The Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects Year 2 after 1st Infusion : Clarke Score without improvement from Baseline	1 Participants

SECONDARY outcome

Timeframe: 1 year and 2 years following the first and last islet transplant(s)

Subjects requiring a 2nd islet infusion at specified timepoints; data utilized were the number of patients who were not successful at gaining and maintaining insulin independence following the 1st infusion and required a 2nd infusion/transplant of islets.

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 1 yr after 1st infusion	2 Participants
The Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 1 yr after last infusion	2 Participants
The Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 2 yrs after 1st infusion	2 Participants
The Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 2 yrs after last infusion	2 Participants

SECONDARY outcome

Timeframe: 1 year and 2 years following the first and last islet transplant(s)

Number of subjects requiring a 3rd islet infusion. Data utilized were the number of patients require a 3rd transplant/infusion of islets due to continued requirement of insulin during study participation.

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
The Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 1 yr after 1st infusion	0 Participants
The Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 1 yr after last infusion	0 Participants
The Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 2 yrs after 1st infusion	0 Participants
The Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects 2 yrs after last infusion	0 Participants

SECONDARY outcome

Timeframe: 1 year and 2 years following the first and last islet transplant(s)

Subjects experience of cardiovascular events and changes in atherogenic profile were examined for the timepoints listed below. Data utilized were baseline lipid labs (triglycerides, total cholesterol, HDL, LDL, and Non-HDL Cholesterol) and lipid labs taken at specified timepoints. An improvement would be an overall improvement of the lipid profile (e.g. reduction in non-HDL cholesterol/overall cholesterol, decrease in LDL, increase in HDL, etc.). Due to the COVID-19 pandemic and increased risk faced by transplant/immunosuppressed individuals, some lipid labs were not collected and data has been indicated as NA due to reduction in sample collection/prioritizing safety labs for subjects.

Outcome measures

Outcome measures
Measure	Main Study Treatment n=2 Participants Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after 1st infusion · Number of subjects experiencing a cardiovascular event	0 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after 1st infusion · Subjects with improvement in Atherogenic Profile at timepoint compared to baseline	NA Participants Due to COVID-19 pandemic, some lipid labs were not done at required time point; data points are not available for either one or both subjects making outcome impossible to assess.
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after 1st infusion · Subjects with worsening Atherogenic Profile at timepoint compared to baseline	NA Participants Due to COVID-19 pandemic, some lipid labs were not done at required time point; data points are not available for either one or both subjects making outcome impossible to assess.
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after 1st infusion · Subjects without change to Atherogenic Profile at timepoint compared to baseline	NA Participants Due to COVID-19 pandemic, some lipid labs were not done at required time point; data points are not available for either one or both subjects making outcome impossible to assess.
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after last infusion · Number of subjects experiencing a cardiovascular event	0 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after last infusion · Subjects with improvement in Atherogenic Profile at timepoint compared to baseline	1 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after last infusion · Subjects with worsening Atherogenic Profile at timepoint compared to baseline	0 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 1 yr after last infusion · Subjects without change to Atherogenic Profile at timepoint compared to baseline	1 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after 1st infusion · Number of subjects experiencing a cardiovascular event	0 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after 1st infusion · Subjects with improvement in Atherogenic Profile at timepoint compared to baseline	NA Participants Due to COVID-19 pandemic, some lipid labs were not done at required time point; data points are not available for either one or both subjects making outcome impossible to assess.
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after 1st infusion · Subjects with worsening Atherogenic Profile at timepoint compared to baseline	NA Participants Due to COVID-19 pandemic, some lipid labs were not done at required time point; data points are not available for either one or both subjects making outcome impossible to assess.
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after 1st infusion · Subjects without change to Atherogenic Profile at timepoint compared to baseline	NA Participants Due to COVID-19 pandemic, some lipid labs were not done at required time point; data points are not available for either one or both subjects making outcome impossible to assess.
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after last infusion · Number of subjects experiencing a cardiovascular event	0 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after last infusion · Subjects with improvement in Atherogenic Profile at timepoint compared to baseline	0 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after last infusion · Subjects with worsening Atherogenic Profile at timepoint compared to baseline	0 Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects 2 yrs after last infusion · Subjects without change to Atherogenic Profile at timepoint compared to baseline	2 Participants

Adverse Events

Main Study Treatment

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Study Treatment n=2 participants at risk Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
Nervous system disorders Seizure	50.0% 1/2 • Number of events 1 • 2 Years
Investigations Tounge Swelling (Allergic Reaction)	50.0% 1/2 • Number of events 1 • 2 Years

Other adverse events

Other adverse events
Measure	Main Study Treatment n=2 participants at risk Alpha 1-Antitrypsin: Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. Islet Transplantation Thymoglobulin: Patients will receive a total of 5 doses between Day -2 and Day +2 Basiliximab: Basiliximab will be used for subsequent transplants. Etanercept: Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
Gastrointestinal disorders Abdominal Pain/Bloating	50.0% 1/2 • Number of events 2 • 2 Years
Cardiac disorders Chest Pain	50.0% 1/2 • Number of events 1 • 2 Years
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1 • 2 Years
General disorders Diaphoresis	50.0% 1/2 • Number of events 1 • 2 Years
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • 2 Years
Infections and infestations Elevated Creatinine	50.0% 1/2 • Number of events 1 • 2 Years
Investigations Elevated Liver Function Tests	50.0% 1/2 • Number of events 1 • 2 Years
Investigations Fever	50.0% 1/2 • Number of events 1 • 2 Years
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 4 • 2 Years
Infections and infestations Shingles	50.0% 1/2 • Number of events 1 • 2 Years
Infections and infestations Upper Respiratory Infection	50.0% 1/2 • Number of events 1 • 2 Years
Infections and infestations Urinary Tract Infection	50.0% 1/2 • Number of events 1 • 2 Years

Additional Information

James Markmann

Massachusetts General Hospital

Phone: 617-643-4533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place