MUNCHR: Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00578643
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 164.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is for patients with chronic granulomatous disease (CGD), which is a disorder of the immune system that puts them at risk for severe infections. CGD is caused by a genetic defect that stops or prevents the white blood cells from killing certain bacteria and fungi. This condition cannot presently be cured by standard treatment with drugs or surgery. Medicine including antibiotics, antifungals, and interferon gamma, may help some patients with CGD; however even with continuous treatment, most patients with CGD will have chronic and recurrent infections. Transfusion of white blood cells may help overcome infection, but white cell transfusions lead to allergic reactions and fever and the benefit of transfusion lasts only a matter of hours. Ultimately, chronic infections can damage or injure the body organs. Injury to the lung or liver can lead to lung or liver failure and death. Medicines used to treat infection can damage body organs too. Infections may become resistant to antibiotic or antifungal treatment, and infections not responding to treatment can be deadly.

It is now known that under specific conditions and with special treatment, blood stem cells (the cells that make blood) can be transplanted from one person to another. Stem cell transplantation has been done for patients with CGD who have a healthy sibling and who share the same immune type (HLA type) as the patient. Stem cell transplantation allows healthy or normal white cells from the stem cell donor to grow or develop in the patient's bone marrow. These healthy white cells can fight infection and prevent future infections for a patient with CGD.

Patients on this study will receive stem cells from a related or unrelated donor. The donor will be closely matched to the patient's immune type but the donor is not a sibling. The reason this treatment is investigational is that we do not know the likelihood of benefit that the patient will receive. It is possible that they will have great benefit, like some of the patients who have been transplanted from a brother or sister. It is possible that the side-effects of treatment may be too severe so that the transplant won't work.

The purpose of this research study is to evaluate whether or not patients with CGD treated with a stem cell transplant from a non-matched and/or non-related donor can have a good outcome from the procedure with an acceptable number of side-effects.

Condition or Disease	Intervention/Treatment	Phase
Chronic Granulomatous Disease	Drug: Busulfan; Biological: Alemtuzumab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Cyclosporine; Procedure: Stem Cell Infusion	Phase 2

Detailed Description

In order to transplant stem cells we will need to give the patient drugs or high-dose chemotherapy to kill or destroy most of the blood forming and immune cells in the bone marrow. This is necessary to allow the donor stem cells to live and grow (engraft) in the bone marrow space. After the drug treatment is completed, the patient will be given the stem cells from the donor. The drug treatment is as follows:

Day -9 Busulfan

Day -8 Busulfan

Day -7 Busulfan

Day -6 Busulfan

Day -5 Alemtuzumab, Fludarabine, Cyclophosphamide

Day -4 Alemtuzumab, Fludarabine, Cyclophosphamide

Day -3 Alemtuzumab, Fludarabine, Cyclophosphamide

Day -2 Alemtuzumab, Fludarabine, Cyclosporine, Cyclophosphamide

Day -1 REST

Day 0 Stem cell infusion

The day after the chemotherapy treatment is completed, the patient will receive the healthy stem cells by vein, like a blood transfusion. Once in the bloodstream, the marrow cells will go to the bone marrow and grow.

It is also possible that if the marrow takes, it will cause a disease known as graft-versus-host disease (GVHD). To prevent GVHD, we will give the patient cyclosporine and Methotrexate. Methotrexate will be administered on Days 1, 3, 6 and 11 after the transplant. The cyclosporine therapy will continue for a longer period of time, however if the patient does not develop GVHD, it will be discontinued by 6 months after the stem cell transplant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HLA Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Jul 31, 2017
• Actual Study Completion Date: Nov 24, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Allogeneic unrelated transplant Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion.

Drug: Busulfan; Days -9 through -6 1 mg/kg initially (based on weight); Other Names: Busulfex ; Biological: Alemtuzumab; Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg; Other Names: Campath ; Drug: Cyclophosphamide; Days -5 through -2 50 mg/kg; Other Names: Cytoxan ; Drug: Fludarabine; Day -5 through Day -2 30 mg/m^2; Other Names: Fludara ; Drug: Cyclosporine; Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.; Other Names: Sandimmune ; Procedure: Stem Cell Infusion; Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Engraftment [28 days post transplant]

   To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.

Secondary Outcome Measures

1. Number of Patients That Have Complete Donor Chimerism After Transplant. [120 days post transplant]

   To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.

2. Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. [Assessed between day 0 and day 100 post transplant]

   To estimate the risk for acute GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.

3. Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant. [Assessed between day 100 and day 365 post transplant]

   To estimate the risk for chronic GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

CGD patients as documented by an abnormal NBT assay in a male patient and/or abnormal NADPH enzyme mutation confirmed by genetic analysis with abnormal NBT.

Patients must not have an HLA genotype identical donor.

Patients must have a 5/6 or 6/6 HLA-matched unrelated donor or a 5/6 or 6/6 HLA phenotype-matched related donor.

Patients must have had at least one serious infection characteristic of those manifested in patients with CGD.

Patients must not have active infection. An active infection may include the following: 1) clinical findings consistent with an infection such as fever, cavitary organ lesions, osteomyelitis; 2) progression of presumed infection based upon findings of diagnostic imaging (two or more studies at least 1 month a part).

No cumulative organ dysfunction that, in the estimation of the treating physicians, will diminish the patient's likelihood to survive this procedure.

Negative pregnancy test for post-pubertal female patients.

Echocardiogram shortening fraction >/= 28%.

DLCO 50% or greater predicted or FEV1 >/= 50% predicted.

EXCLUSION CRITERIA:

Active or uncontrolled infection (e.g. lung infection, cavitary organ lesions, osteomyelitis).

Markedly elevated C reactive protein or sedimentation rate relative to patient's baseline.

Invasive bone or bone marrow disease.

Lack of potential hematologic blood product donors in the past (related to McLeod phenotype).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

• Principal Investigator: Robert Krance, MD, Baylor College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 13, 2018

More Information

Publications

None provided.

• Responsible Party: Robert Krance, Professor, Hematology Oncology, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00578643
• Other Study ID Numbers: 14771-MUNCHR
• First Posted: Dec 21, 2007
• Last Update Posted: Nov 9, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Robert Krance, Professor, Hematology Oncology, Baylor College of Medicine: Stem Cell Transplant; Chronic Granulomatous Disease; Fludarabine; Busulfan; Cyclophosphamide
• Additional relevant MeSH terms: Granuloma; Granulomatous Disease, Chronic; Cyclosporine; Cyclophosphamide; Busulfan; Fludarabine; Alemtuzumab; Cyclosporins

Study Results

Participant Flow

Arm/Group Title	Allogeneic Unrelated Transplant
Arm/Group Description	Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
Period Title: Overall Study
STARTED	15
COMPLETED	13
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Allogeneic Unrelated Transplant
Arm/Group Description	Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
Overall Participants	15
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	6
Sex: Female, Male (Count of Participants)
Female	1 6.7%
Male	14 93.3%
Race/Ethnicity, Customized (Count of Participants)
White	7 46.7%
Black or African American	1 6.7%
Asian	1 6.7%
Hispanic or Latino	5 33.3%
Unknown	1 6.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Engraftment
Description	To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.
Time Frame	28 days post transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Allogeneic Unrelated Transplant
Arm/Group Description	Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
Measure Participants	15
Number [percentage of participants]	100 666.7%

2. Secondary Outcome

Title	Number of Patients That Have Complete Donor Chimerism After Transplant.
Description	To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.
Time Frame	120 days post transplant

Outcome Measure Data

Analysis Population Description

One patient died on day 62 post transplant and was not included in the analysis.

Arm/Group Title	Allogeneic Unrelated Transplant
Arm/Group Description	Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
Measure Participants	14
Number [participants]	13 86.7%

3. Secondary Outcome

Title	Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant.
Description	To estimate the risk for acute GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.
Time Frame	Assessed between day 0 and day 100 post transplant

Outcome Measure Data

Analysis Population Description

One patient who died on day 62 post transplant without developing acute GVHD was not assessed for this Outcome Measure.

Arm/Group Title	Allogeneic Unrelated Transplant
Arm/Group Description	Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
Measure Participants	14
None	8 53.3%
Grade I	6 40%
Grade II	0 0%
Grade III-IV	0 0%

4. Secondary Outcome

Title	Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant.
Description	To estimate the risk for chronic GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.
Time Frame	Assessed between day 100 and day 365 post transplant

Outcome Measure Data

Analysis Population Description

One patient died on day 62 post transplant, and one patient was lost to F/U on day 163 post transplant. They were not assessed for this Outcome Measure.

Arm/Group Title	Allogeneic Unrelated Transplant
Arm/Group Description	Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
Measure Participants	13
Yes	0 0%
No	13 86.7%

Adverse Events

Time Frame	Adverse events excluding fevers and hematological toxicities were collected up to 30 days after transplant. SAEs excluding fevers and hematological toxicities were collected up to 100 days after transplant.
Adverse Event Reporting Description	An adverse event was defined as grade III or grade IV toxicity by the NCI Common Toxicity Criteria Version 3.0. A SAE is any adverse event that was fatal, life threatening , required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s) or considered a significant medical event by the investigator.
Arm/Group Title	Allogeneic Unrelated Transplant
Arm/Group Description	Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
All Cause Mortality
	Allogeneic Unrelated Transplant
	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)
Serious Adverse Events
	Allogeneic Unrelated Transplant
	Affected / at Risk (%)	# Events
Total	9/15 (60%)
Cardiac disorders
Hypertension	1/15 (6.7%)	1
Gastrointestinal disorders
Diarrhea patients without colostomy	1/15 (6.7%)	1
Gastrointestinal-Other: Eosinofilic enteritis	1/15 (6.7%)	1
Pancreatitis	1/15 (6.7%)	1
General disorders
Constitutional Symptoms - Other: Multiorgan failure	1/15 (6.7%)	1
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)	1/15 (6.7%)	1
Infections and infestations
Hematuria (in the absence of vaginal bleeding)	1/15 (6.7%)	1
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e	1/15 (6.7%)	2
Infection without neutropenia	1/15 (6.7%)	1
Infection - Other: Adenovirus viremia, BK viruria, CMV viremia	1/15 (6.7%)	1
Infection - Other: Hemorrhagic cystitis with BK virus, adenovirus, and CMV	1/15 (6.7%)	1
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood	1/15 (6.7%)	1
Metabolism and nutrition disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase)	1/15 (6.7%)	1
Nervous system disorders
Seizure	1/15 (6.7%)	1
Renal and urinary disorders
Renal failure	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant) 1	1/15 (6.7%)	1
Pneumonitis/pulmonary infiltrates	1/15 (6.7%)	1
Pulmonary/Upper Respiratory - Other: Respiratory distress	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	Allogeneic Unrelated Transplant
	Affected / at Risk (%)	# Events
Total	14/15 (93.3%)
Cardiac disorders
Hypertension	3/15 (20%)	3
Gastrointestinal disorders
Dehydration	1/15 (6.7%)	1
Diarrhea	1/15 (6.7%)	1
Diarrhea patients without colostomy	1/15 (6.7%)	3
Stomatitis/pharyngitis (oral/pharyngeal mucositis)	1/15 (6.7%)	1
Hepatobiliary disorders
GGT (Gamma-Glutamyl transpeptidase)	2/15 (13.3%)	3
SGOT (AST) (serum glutamic oxaloacetic transaminase)	2/15 (13.3%)	2
SGPT (ALT) (serum glutamic pyruvic transaminase)	1/15 (6.7%)	1
Infections and infestations
Hematuria (in the absence of vaginal bleeding)	1/15 (6.7%)	1
Catheter-related infection	1/15 (6.7%)	1
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia(ANC<1.0x10e9/L)	3/15 (20%)	3
Infection without neutropenia	2/15 (13.3%)	5
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)	1/15 (6.7%)	1
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)	1/15 (6.7%)	1
AST, SGOT(serum glutamic oxaloacetic transaminase)	5/15 (33.3%)	6
Acidosis (metabolic or respiratory)	1/15 (6.7%)	2
Amylase	1/15 (6.7%)	2
Calcium, serum-low (hypocalcemia)	1/15 (6.7%)	1
GGT (gamma-Glutamyl transpeptidase)	1/15 (6.7%)	1
Hypocalcemia	2/15 (13.3%)	2
Hyponatremia	2/15 (13.3%)	2
Lipase	1/15 (6.7%)	1
Nervous system disorders
Seizure(s)	1/15 (6.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.