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Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00260689
Recruitment Status : Completed
First Posted : December 1, 2005
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Immunosuppresion
Thrombocytopenia
Pancytopenia
Neutropenia
Interventions Biological: Anti-thymocyte globulin (rabbit)
Biological: Anti-thymocyte globulin (horse)
Drug: Cyclosporine
Drug: Alemtuzumab
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Hide Arm/Group Description Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA) Alemtuzumab (Campath) administered for 10 days
Period Title: Overall Study
Started 60 60 16
Completed 19 11 1
Not Completed 41 49 15
Arm/Group Title Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab Total
Hide Arm/Group Description Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA) Alemtuzumab (Campath) administered for 10 days Total of all reporting groups
Overall Number of Baseline Participants 60 60 16 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 16 participants 136 participants
<=18 years
14
  23.3%
21
  35.0%
4
  25.0%
39
  28.7%
Between 18 and 65 years
38
  63.3%
35
  58.3%
8
  50.0%
81
  59.6%
>=65 years
8
  13.3%
4
   6.7%
4
  25.0%
16
  11.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 16 participants 136 participants
Female
27
  45.0%
23
  38.3%
4
  25.0%
54
  39.7%
Male
33
  55.0%
37
  61.7%
12
  75.0%
82
  60.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 16 participants 136 participants
Hispanic or Latino
9
  15.0%
13
  21.7%
7
  43.8%
29
  21.3%
Not Hispanic or Latino
50
  83.3%
44
  73.3%
9
  56.3%
103
  75.7%
Unknown or Not Reported
1
   1.7%
3
   5.0%
0
   0.0%
4
   2.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 16 participants 136 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   8.3%
2
   3.3%
1
   6.3%
8
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  25.0%
20
  33.3%
1
   6.3%
36
  26.5%
White
29
  48.3%
24
  40.0%
7
  43.8%
60
  44.1%
More than one race
2
   3.3%
0
   0.0%
0
   0.0%
2
   1.5%
Unknown or Not Reported
9
  15.0%
14
  23.3%
7
  43.8%
30
  22.1%
1.Primary Outcome
Title Hematologic Response
Hide Description

Hematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)

  • Absolute neutrophil count > 500/ μL
  • Platelet count > 20,000/ μL
  • Reticulocyte count > 60,000/ μL

Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Hide Arm/Group Description:
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
Alemtuzumab (Campath) administered for 10 days
Overall Number of Participants Analyzed 60 60 16
Measure Type: Count of Participants
Unit of Measure: Participants
38
  63.3%
20
  33.3%
3
  18.8%
2.Primary Outcome
Title Hematologic Response
Hide Description

Hematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)

  • Absolute neutrophil count > 500/ μL
  • Platelet count > 20,000/ μL
  • Reticulocyte count > 60,000/ μL

Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Hide Arm/Group Description:
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
Alemtuzumab (Campath) administered for 10 days
Overall Number of Participants Analyzed 60 60 16
Measure Type: Count of Participants
Unit of Measure: Participants
41
  68.3%
22
  36.7%
3
  18.8%
3.Primary Outcome
Title Hematologic Response
Hide Description

Hematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)

  • Absolute neutrophil count > 500/ μL
  • Platelet count > 20,000/ μL
  • Reticulocyte count > 60,000/ μL

Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Hide Arm/Group Description:
Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
Alemtuzumab (Campath) administered for 10 days
Overall Number of Participants Analyzed 60 60 16
Measure Type: Count of Participants
Unit of Measure: Participants
40
  66.7%
18
  30.0%
2
  12.5%
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Hide Arm/Group Description Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA) Alemtuzumab (Campath) administered for 10 days
All-Cause Mortality
Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/60 (18.33%)   18/60 (30.00%)   7/16 (43.75%) 
Hide Serious Adverse Events
Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/60 (11.67%)   11/60 (18.33%)   6/16 (37.50%) 
Blood and lymphatic system disorders       
CNS hemorrhage/bleeding   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Edema: limb   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Cardiac disorders       
Cardiac troponin I   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Hypertension   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Supraventricular arrhythmia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Immune system disorders       
Serum sickness   2/60 (3.33%)  4/60 (6.67%)  0/16 (0.00%) 
Serum sickness/Infection   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Infections and infestations       
Infection (documented clinically or microbiologically with grade 3 or 4 neutropenia)   3/60 (5.00%)  1/60 (1.67%)  5/16 (31.25%) 
Infection without neutropenia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Metabolism and nutrition disorders       
Creatinine (grade 2)   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Hypokalemia   0/60 (0.00%)  0/60 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders       
Arthralgia (joint pain)   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Nervous system disorders       
Seizures   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Horse ATG/CsA Taper Rabbit ATG/CsA Alemtuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/60 (60.00%)   39/60 (65.00%)   15/16 (93.75%) 
Blood and lymphatic system disorders       
edema   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
edema - mild lower extremity   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
gingival hypertrophy   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Hemolysis   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
lower extremity edema   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
lower extremity swelling   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
slight edema pitting   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
slight pitting edema   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
swelling (lower extremity)   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
swelling ankles   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
swelling feet and hands   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Cardiac disorders       
bradycardia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Edema, ankles   2/60 (3.33%)  1/60 (1.67%)  0/16 (0.00%) 
Edema, lower legs   3/60 (5.00%)  1/60 (1.67%)  1/16 (6.25%) 
fluid overload   2/60 (3.33%)  1/60 (1.67%)  0/16 (0.00%) 
h Blood pressure   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
h BP   3/60 (5.00%)  1/60 (1.67%)  0/16 (0.00%) 
high blood pressure   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Hypertension   8/60 (13.33%)  9/60 (15.00%)  3/16 (18.75%) 
hypotension   2/60 (3.33%)  3/60 (5.00%)  0/16 (0.00%) 
i SBP   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
irregular pulse   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
S tachycardia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
substernal pressure   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Supraventricular tachycardia   0/60 (0.00%)  0/60 (0.00%)  1/16 (6.25%) 
Tachycardia   2/60 (3.33%)  1/60 (1.67%)  1/16 (6.25%) 
Endocrine disorders       
Hot flashes   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Hypothyroidism, subclinical   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Eye disorders       
Photophobia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
abdominal distension   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
abdominal gas   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
abdominal pain   2/60 (3.33%)  0/60 (0.00%)  0/16 (0.00%) 
abdominal pain with loose stools   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
bleeding, swollen gums   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
bloated   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
decreased   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
dehydration   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
diarrhea   5/60 (8.33%)  8/60 (13.33%)  0/16 (0.00%) 
Gingival hyperplasia   2/60 (3.33%)  4/60 (6.67%)  2/16 (12.50%) 
gingivial hyperplasia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
gingivial hyperplasia - mild   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
gingivitis   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
gum hyperplasia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
gum hypertrophy   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Heartburn   3/60 (5.00%)  1/60 (1.67%)  1/16 (6.25%) 
i K+   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Indigestion   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
loose stool   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Nausea   3/60 (5.00%)  4/60 (6.67%)  0/16 (0.00%) 
nausea + vomiting   2/60 (3.33%)  1/60 (1.67%)  0/16 (0.00%) 
poor appetite   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
vomiting   2/60 (3.33%)  3/60 (5.00%)  0/16 (0.00%) 
General disorders       
Abdominal   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
abdominal pain   1/60 (1.67%)  2/60 (3.33%)  0/16 (0.00%) 
Abdominal, cramps   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
body aches   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
chest discomfort   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
chest pain   0/60 (0.00%)  2/60 (3.33%)  0/16 (0.00%) 
Chest pressure   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
chest tightness   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
chills   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
chills/rigors   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
epigastric pain   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
fever   6/60 (10.00%)  5/60 (8.33%)  0/16 (0.00%) 
Headache   10/60 (16.67%)  6/60 (10.00%)  1/16 (6.25%) 
leg pain   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Localized, back   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Localized, feet (burning), knee   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Localized, low back   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Localized, soles of feet, legs   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Localized, Throat   0/60 (0.00%)  0/60 (0.00%)  1/16 (6.25%) 
Localized, throat, abdomen   0/60 (0.00%)  0/60 (0.00%)  1/16 (6.25%) 
Localized, Wrist, bilateral   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
low back pain   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Myalgia (general)   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Myalgia, arthralgia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Myalgia, back   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Myalgia, calves   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
neutropenic fever   2/60 (3.33%)  3/60 (5.00%)  0/16 (0.00%) 
retrosternal chest pain   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
rigor   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
rigors   5/60 (8.33%)  2/60 (3.33%)  0/16 (0.00%) 
stomach discomfort   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
tired   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
weight gain   2/60 (3.33%)  2/60 (3.33%)  0/16 (0.00%) 
weight increase   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
weight loss   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Hepatobiliary disorders       
Elevated LFT's   9/60 (15.00%)  9/60 (15.00%)  5/16 (31.25%) 
Elevated t. bili   5/60 (8.33%)  6/60 (10.00%)  0/16 (0.00%) 
Immune system disorders       
flu-like symptoms   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
joint Pain   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Labeled infusion related   28/60 (46.67%)  31/60 (51.67%)  15/16 (93.75%) 
Serum sickness   2/60 (3.33%)  5/60 (8.33%)  0/16 (0.00%) 
swelling   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
throat swelling   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Infections and infestations       
C. diff colitis   0/60 (0.00%)  3/60 (5.00%)  0/16 (0.00%) 
C. diff colitis and Blastocystis hominis   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Gingivitis   3/60 (5.00%)  1/60 (1.67%)  0/16 (0.00%) 
Mouth sores   3/60 (5.00%)  3/60 (5.00%)  1/16 (6.25%) 
Mouth sores (neg. Cxs)   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Shingles   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Trush   1/60 (1.67%)  1/60 (1.67%)  1/16 (6.25%) 
Upper Respiratory Tract   0/60 (0.00%)  1/60 (1.67%)  1/16 (6.25%) 
Metabolism and nutrition disorders       
h ALT   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
h ALT/di bili   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
h AST   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
h creatinine   3/60 (5.00%)  4/60 (6.67%)  0/16 (0.00%) 
h creatinine -mild   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
h K   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
h LDH   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
h LFT   2/60 (3.33%)  0/60 (0.00%)  0/16 (0.00%) 
h LFT, creatinine   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
h LFTs   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
h PT, PTT   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Hyperglicemia   2/60 (3.33%)  2/60 (3.33%)  1/16 (6.25%) 
hyperglycemia   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
hyperkalemia   2/60 (3.33%)  0/60 (0.00%)  0/16 (0.00%) 
hypernatremia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
hypertension   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
hypoglycemia   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
hypokalemia   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
hypomagnesia   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
i magnesium   2/60 (3.33%)  2/60 (3.33%)  0/16 (0.00%) 
LFT abnormal   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
low albumin   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
renal failure   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
Bursitis   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Cramps   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
Nervous system disorders       
anxiety   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Anxiety, irritability   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
dizziness   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Insomnia   0/60 (0.00%)  2/60 (3.33%)  1/16 (6.25%) 
numbness   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Numbness fingers, wrists   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
numbness/tingling (bilateral lower extremities)   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
parastesias   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Perioral tingling   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Peripheral neuropathy, CsA induced   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
tingling   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Tremor, hands   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
tremors   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Renal and urinary disorders       
acute kidney injury   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Dysuria   0/60 (0.00%)  1/60 (1.67%)  1/16 (6.25%) 
mild renal insufficiency   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
cough   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
crackles   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
crackles in lungs   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
crackles lungs   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
dry cough   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
short of breath   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
sob   2/60 (3.33%)  1/60 (1.67%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne   1/60 (1.67%)  1/60 (1.67%)  0/16 (0.00%) 
Body hair growth   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Dandruff   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Erythema, LE   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
erythematous rash   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
hair growth   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
increased hair growth   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
itchy palms   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
palm itching   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
palms slightly red   0/60 (0.00%)  1/60 (1.67%)  0/16 (0.00%) 
Rash   2/60 (3.33%)  2/60 (3.33%)  0/16 (0.00%) 
rash (arms)   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
rash - mild   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
rash face   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Rash, face   0/60 (0.00%)  0/60 (0.00%)  1/16 (6.25%) 
rash, hives, itching   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
urticarial rash -mild   1/60 (1.67%)  0/60 (0.00%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
Originally, there were 3 regimens: h-ATG/CsA ; r-ATG/CsA; alemtuzumab. Subjects not responding to r-ATG will cross over to alemtuzumab, and subjects failing alemtuzumab will cross over to r-ATG. Subjects not responding to h-ATG/CsA will go off study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Danielle Townsley MD
Organization: NHLBI, NIH
Phone: 301-402-3477
EMail: townsleydm@nhlbi.nih.gov
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT00260689    
Other Study ID Numbers: 060034
06-H-0034 ( Other Identifier: NIH )
First Submitted: December 1, 2005
First Posted: December 1, 2005
Results First Submitted: May 16, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017