A Research Trial of Aralast in New Onset Diabetes (RETAIN)
Study Details
Study Description
Brief Summary
The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to injuries) that affects the cells thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D).
All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD) and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in Part II (NCT01183455, Phase II Clinical Trial) will begin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Researchers are interested in conducting this study to assess whether Aralast NP (AAT, Alpha-1 Antitrypsin ) will help slow the progression of T1DM.
Part I of this study has two parts:-1a and -1b:
Part 1a (Complete): An open-label, dose-escalation, PK, PD and safety study. Participants receive 12 intravenous (IV) infusions of Aralast NP. Infusions 1 through 6 are administered at 45 mg/kg/wk and infusions 7 through 12 are administered at 90 mg/kg/wk.
Part Ia consists of two groups:
-
Subjects aged 16 - 35 years at enrollment with new-onset T1DM
-
Subjects aged 8 -15 years at enrollment with new-onset T1DM.
Part 1b (study terminated prior to subject enrollment): An open-label, dose-escalation PK, PD and safety study in which participants receive 12 infusions of Aralast NP. Infusions 1 through 6 are administered at 90 mg/kg/wk and infusions 7 through 12 are administered at 180 mg/kg/wk. Part Ib consists of two groups:
-
Subjects aged 16 - 35 years at enrollment with new-onset T1DM
-
Subjects 8 - 15 years at enrollment with new-onset T1DM.
Participants in Part Ib do not roll over into Part II (Refer to NCT01183455).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. |
Biological: Aralast NP 45 mg dose
- 45 mg/kg/week
Other Names:
Biological: Aralast NP 90 mg dose
- 90 mg/kg/week
Other Names:
|
| Experimental: Part 1a (Aralast NP)-Subjects 8-15 Yrs Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. |
Biological: Aralast NP 45 mg dose
- 45 mg/kg/week
Other Names:
Biological: Aralast NP 90 mg dose
- 90 mg/kg/week
Other Names:
|
| Experimental: Part 1b (Aralast NP)--Subjects Aged 18-35 Yrs Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. |
Biological: Aralast NP 90 mg dose
- 90 mg/kg/week
Other Names:
Biological: Aralast NP 180 mg dose
- 180 mg/kg/week
Other Names:
|
| Experimental: Part 1b (Aralast NP)-Subjects 8-17 Yrs Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. |
Biological: Aralast NP 90 mg dose
- 90 mg/kg/week
Other Names:
Biological: Aralast NP 180 mg dose
- 180 mg/kg/week
Other Names:
|
Outcome Measures
Primary Outcome Measures
- C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52 [Week 52]
No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with T1DM within the past 100 days (of enrollment)
-
Positive for at least one diabetes-related autoantibody (Anti-GAD; Anti-insulin, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody and/or ICA, or ZnT8.)
-
Peak stimulated C-peptide level > 0.2 pmol/mL following a mixed meal tolerance test (MMTT)
Exclusion Criteria:
-
Severe active disease (chronic active hepatitis; cardiac, pulmonary disease, hepatic, renal or immunodeficiency)
-
History of any bleeding or clotting factor deficiencies, or stroke
-
History of vascular disease or significant vascular abnormalities
-
Positive serology of exposure to (hepatitis B virus) HBV, HCV (hepatitis C virus), HIV (human immunodeficiency virus) or toxoplasmosis
-
Clinically active infection with EBV (Epstein-Barr virus), CMV (cytomegalovirus), or tuberculosis(TB)
-
Prior or current use of oral, inhaled or intranasal glucocorticoids, or any medication known to cause a significant, ongoing change in the course of T1DM or immunologic status
-
Prior treatment with Alpha 1-Antitrypsin (Aralast NP, AAT) or hypersensitivity to alpha 1-antitrypsin or human plasma-derived products
-
Current or prior (within the last 30 days) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin
-
Current use of any medication known to influence glucose tolerance (e.g., beta-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine anti-malarial drugs, lithium, niacin)
-
Females who are pregnant or lactating, or are unwilling to defer pregnancy during study participation
-
IgA (immunoglobulin A) deficiency
-
Uncontrolled hypertension
-
Current life-threatening malignancy
-
Any condition that in the investigator's opinion may compromise study participation or may confound the interpretation of the study results.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | RADY Children's Hospital (University of California, San Diego) | San Diego | California | United States | 92093 |
| 2 | Barbara Davis Center (University of Colorado) | Aurora | Colorado | United States | 80045 |
| 3 | Yale University | New Haven | Connecticut | United States | 06520 |
| 4 | Atlanta Diabetes Associates | Atlanta | Georgia | United States | 30309 |
| 5 | Children's Hospital of Atlanta (Emory University) | Atlanta | Georgia | United States | 30322 |
| 6 | University of Iowa Children's Hospital | Iowa City | Iowa | United States | 52242 |
| 7 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 8 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 9 | Joslin Diabetes Center | Boston | Massachusetts | United States | 02215 |
| 10 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
| 11 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 12 | Naomi Berrie Diabetes Center (Columbia University) | New York | New York | United States | 10032 |
| 13 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 14 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 15 | Pacific Northwest Research Institute-University of Washington | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Immune Tolerance Network (ITN)
- Juvenile Diabetes Research Foundation
Investigators
- Study Chair: Gordon Weir, MD, Joslin Diabetes Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- National Institute of Allergy and Infectious Diseases (NIAID) website
- Immune Tolerance Network (ITN) website
- Juvenile Diabetes Research Foundation (JDRF)
Publications
None provided.- DAIT ITN041AI Part 1
Study Results
Participant Flow
| Recruitment Details | Twelve of the fifteen centers enrolled a total of 17 newly diagnosed (within 100 days of Visit 0 first low dose infusion) Type 1 Diabetes Mellitus participants. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs | Part 1a (Aralast NP)-Subjects 8-15 Yrs | Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs | Part 1b (Aralast NP)-Subjects 8-17 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. Aralast NP 90 mg dose: - 90 mg/kg/week Aralast NP 180 mg dose: - 180 mg/kg/week | Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. Aralast NP 90 mg dose: - 90 mg/kg/week Aralast NP 180 mg dose: - 180 mg/kg/week |
| Period Title: Overall Study | ||||
| STARTED | 8 | 9 | 0 | 0 |
| COMPLETED | 5 | 7 | 0 | 0 |
| NOT COMPLETED | 3 | 2 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs | Part 1a (Aralast NP)-Subjects 8-15 Yrs | Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs | Part 1b (Aralast NP)-Subjects 8-17 Yrs | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. Aralast NP 90 mg dose: - 90 mg/kg/week Aralast NP 180 mg dose: - 180 mg/kg/week | Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. Aralast NP 90 mg dose: - 90 mg/kg/week Aralast NP 180 mg dose: - 180 mg/kg/week | Total of all reporting groups |
| Overall Participants | 8 | 9 | 0 | 0 | 17 |
| Age (Count of Participants) | |||||
| <=18 years |
4
50%
|
9
100%
|
13
Infinity
|
||
| Between 18 and 65 years |
4
50%
|
0
0%
|
4
Infinity
|
||
| >=65 years |
0
0%
|
0
0%
|
0
NaN
|
||
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
20.6
(5.7)
|
10.7
(2.2)
|
15.4
(6.6)
|
||
| Sex: Female, Male (Count of Participants) | |||||
| Female |
3
37.5%
|
3
33.3%
|
6
Infinity
|
||
| Male |
5
62.5%
|
6
66.7%
|
11
Infinity
|
||
| Region of Enrollment (participants) [Number] | |||||
| United States |
8
100%
|
9
100%
|
17
Infinity
|
||
Outcome Measures
| Title | C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52 |
|---|---|
| Description | No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Enrolled Sample |
| Arm/Group Title | Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs | Part 1a (Aralast NP)-Subjects 8-15 Yrs | Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs | Part 1b (Aralast NP)-Subjects 8-17 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. Aralast NP 90 mg dose: - 90 mg/kg/week Aralast NP 180 mg dose: - 180 mg/kg/week | Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions. Aralast NP 90 mg dose: - 90 mg/kg/week Aralast NP 180 mg dose: - 180 mg/kg/week |
| Measure Participants | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | Adverse events were collected for 2.5 years, from the start of the study in January 2011 until the last participant completed the study in July 2013. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were collected from the time a participant signed informed consent until the time an event resolved or until 30 days after the participant completed study treatment, whichever came first. | |||
| Arm/Group Title | Subjects Aged 16 - 35 Years | Subjects Aged 8 - 15 Years | ||
| Arm/Group Description | Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions. | ||
All Cause Mortality |
||||
| Subjects Aged 16 - 35 Years | Subjects Aged 8 - 15 Years | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Subjects Aged 16 - 35 Years | Subjects Aged 8 - 15 Years | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/8 (25%) | 1/9 (11.1%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetic ketoacidosis | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Hypoglycaemia | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal pain | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Subjects Aged 16 - 35 Years | Subjects Aged 8 - 15 Years | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/8 (100%) | 8/9 (88.9%) | ||
| Endocrine disorders | ||||
| Goitre | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Eye disorders | ||||
| Blepharitis | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Conjunctivitis | 0/8 (0%) | 0 | 1/9 (11.1%) | 2 |
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Abdominal pain | 0/8 (0%) | 0 | 1/9 (11.1%) | 4 |
| Abdominal pain upper | 0/8 (0%) | 0 | 2/9 (22.2%) | 12 |
| Constipation | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Diarrhoea | 1/8 (12.5%) | 1 | 2/9 (22.2%) | 3 |
| Nausea | 1/8 (12.5%) | 1 | 4/9 (44.4%) | 7 |
| Vomiting | 0/8 (0%) | 0 | 4/9 (44.4%) | 5 |
| General disorders | ||||
| Chest pain | 1/8 (12.5%) | 1 | 2/9 (22.2%) | 2 |
| Influenza like illness | 1/8 (12.5%) | 1 | 1/9 (11.1%) | 1 |
| Infusion site haematoma | 0/8 (0%) | 0 | 1/9 (11.1%) | 4 |
| Infusion site pain | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Injection site haematoma | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Pyrexia | 1/8 (12.5%) | 1 | 3/9 (33.3%) | 3 |
| Infections and infestations | ||||
| Ear infection | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Fungal infection | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Gastroenteritis | 0/8 (0%) | 0 | 2/9 (22.2%) | 2 |
| Gastroenteritis viral | 0/8 (0%) | 0 | 3/9 (33.3%) | 3 |
| Influenza | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Kidney infection | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Nasopharyngitis | 2/8 (25%) | 2 | 2/9 (22.2%) | 3 |
| Otitis externa | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Pharyngitis streptococcal | 1/8 (12.5%) | 1 | 1/9 (11.1%) | 1 |
| Pneumonia | 1/8 (12.5%) | 1 | 1/9 (11.1%) | 1 |
| Respiratory tract infection viral | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Sinusitis | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Streptococcal infection | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Tooth infection | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Upper respiratory tract infection | 0/8 (0%) | 0 | 4/9 (44.4%) | 10 |
| Urinary tract infection | 2/8 (25%) | 9 | 0/9 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Concussion | 0/8 (0%) | 0 | 1/9 (11.1%) | 2 |
| Contusion | 1/8 (12.5%) | 1 | 3/9 (33.3%) | 3 |
| Fibula fracture | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Foot fracture | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Hand fracture | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Procedural pain | 1/8 (12.5%) | 3 | 1/9 (11.1%) | 1 |
| Radius fracture | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Upper limb fracture | 0/8 (0%) | 0 | 1/9 (11.1%) | 2 |
| Investigations | ||||
| Fibrin D dimer increased | 0/8 (0%) | 0 | 3/9 (33.3%) | 3 |
| Glycosylated haemoglobin increased | 0/8 (0%) | 0 | 2/9 (22.2%) | 2 |
| Lymphocyte count decreased | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Lymphocyte count increased | 1/8 (12.5%) | 2 | 0/9 (0%) | 0 |
| Neutrophil count decreased | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| White blood cell count decreased | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Metabolism and nutrition disorders | ||||
| Hyperglycaemia | 0/8 (0%) | 0 | 1/9 (11.1%) | 4 |
| Hypoglycaemia | 7/8 (87.5%) | 69 | 8/9 (88.9%) | 104 |
| Vitamin D deficiency | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3/8 (37.5%) | 3 | 0/9 (0%) | 0 |
| Back pain | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Muscle spasms | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Musculoskeletal pain | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Myalgia | 0/8 (0%) | 0 | 1/9 (11.1%) | 4 |
| Neck pain | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Pain in extremity | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Skin papilloma | 0/8 (0%) | 0 | 1/9 (11.1%) | 2 |
| Nervous system disorders | ||||
| Dizziness | 0/8 (0%) | 0 | 2/9 (22.2%) | 2 |
| Headache | 2/8 (25%) | 2 | 4/9 (44.4%) | 77 |
| Sinus headache | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Syncope | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Psychiatric disorders | ||||
| Panic attack | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Renal and urinary disorders | ||||
| Hypercalciuria | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Ketonuria | 0/8 (0%) | 0 | 2/9 (22.2%) | 4 |
| Nephrolithiasis | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 3/8 (37.5%) | 3 | 2/9 (22.2%) | 4 |
| Nasal congestion | 3/8 (37.5%) | 3 | 2/9 (22.2%) | 2 |
| Oropharyngeal pain | 0/8 (0%) | 0 | 2/9 (22.2%) | 9 |
| Respiratory tract congestion | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Rhinitis allergic | 1/8 (12.5%) | 1 | 1/9 (11.1%) | 1 |
| Upper respiratory tract congestion | 0/8 (0%) | 0 | 1/9 (11.1%) | 2 |
| Upper-airway cough syndrome | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Dry skin | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Eczema | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Rash | 1/8 (12.5%) | 3 | 3/9 (33.3%) | 4 |
| Rash papular | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
| Rash pruritic | 0/8 (0%) | 0 | 1/9 (11.1%) | 2 |
| Skin mass | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Urticaria | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
| Name/Title | Director, Clinical Research Operations Program |
|---|---|
| Organization | DAIT/NIAID |
| Phone | 301-594-7669 |
| DAITClinicalTrialsGov@niaid.nih.gov |
- DAIT ITN041AI Part 1