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Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (deLTa)

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ClinicalTrials.gov Identifier: NCT02188719
Recruitment Status : Terminated (The trial could not be completed within the grant timeline.)
First Posted : July 14, 2014
Results First Posted : July 20, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Rho Federal Systems Division, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Transplantation
Interventions Biological: Anti-Thymocyte Globulin - Rabbit
Biological: darTreg Infusion
Drug: Everolimus
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Drug: Prednisone
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Anti-Infective Prophylaxis
Procedure: Leukapheresis
Procedure: Blood draws
Procedure: Liver biopsies
Procedure: Liver transplantation
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description Participants received Thymoglobulin®+EVR IS but will not receive darTregs Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells. Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort. Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
Period Title: Overall Study
Started 6 9 0 0
Completed 6 8 0 0
Not Completed 0 1 0 0
Reason Not Completed
Screen B Ineligible (Page 55, Protocol)             0             1             0             0
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Total
Hide Arm/Group Description Participants received Thymoglobulin®+EVR IS but will not receive darTregs Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells. Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort. Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort. Total of all reporting groups
Overall Number of Baseline Participants 6 9 0 0 15
Hide Baseline Analysis Population Description
All participants assigned to Treatment Cohorts after transplantation.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0 0
0
   0.0%
Between 18 and 65 years
5
  83.3%
6
  66.7%
0 0
11
  73.3%
>=65 years
1
  16.7%
3
  33.3%
0 0
4
  26.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
59  (5.5) 62  (4.2) 61  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
Female
2
  33.3%
0
   0.0%
2
  13.3%
Male
4
  66.7%
9
 100.0%
13
  86.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
Hispanic or Latino
1
  16.7%
1
  11.1%
2
  13.3%
Not Hispanic or Latino
5
  83.3%
8
  88.9%
13
  86.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  16.7%
5
  55.6%
6
  40.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
  83.3%
4
  44.4%
9
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Count of Participants
United States Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
6 9 15
Alanine Aminotransferase (ALT)   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
47.0  (66.6) 216.4  (543.4) 148.7  (421.5)
[1]
Measure Description: Normal Range in Adults: 7-41 U/L.
Alkaline Phosphatase   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
64.0  (17.3) 102.8  (44.4) 87.3  (40.2)
[1]
Measure Description: Normal Range in Adults: 33-96 U/L.
Gamma-Glutamyl Transferase (GGT)   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 6 participants 9 participants 0 participants 0 participants 15 participants
40.0  (11.3) 115.8  (97.0) 100.6  (91.4)
[1]
Measure Description: Normal Range in Adults: 9-58 U/L.
1.Primary Outcome
Title Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
Hide Description

Biopsy-proven acute rejection graded as Mild, Moderate or Severe, per 1997 Banff classification. Chronic Rejection graded using Banff 2000 classification.

References: 1.) Banff Schema for Grading Liver Allograft Rejection: An International Consensus Document developed by an international panel of experts in liver transplantation pathology, hepatology, and surgery (Hepatology 1997; 25(3): 658-663). 2.) Update of the International Banff Schema for Liver Allograft Rejection: Working Recommendations for the Histopathologic Staging and Reporting of Chronic Rejection (Hepatology 2000; 31(3): 792-799).

Time Frame Transplantation to 40 Weeks Post Transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
All transplanted participants.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
Overall Number of Participants Analyzed 6 9 0 0
Measure Type: Number
Unit of Measure: Percent of Participants
Mild Acute Rejection 0 11.1
Moderate Acute Rejection 0 0
Severe Acute Rejection 0 0
Chronic Rejection 0 0
2.Primary Outcome
Title Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s)
Hide Description

The severity of infectious adverse events (AEs) was classified into grades as follows:

  • Grade 1 = asymptomatic; clinical or diagnostic observation only; intervention with oral antibiotic, antifungal, or antiviral agent only; no invasive intervention required
  • Grade 2 = symptomatic; intervention with intravenous antibiotic, antifungal, or antiviral agent; invasive intervention may be required
  • Grade 3 = any infection associated with hemodynamic compromise requiring pressors; any infection necessitating intensive care unit level of care; any infection necessitating operative intervention; any infection involving the central nervous system; any infection with a positive fungal blood culture; any proven or probable aspergillus infection; any tissue invasive fungal infection; any pneumocystis jiroveci infection
  • Grade 4 = life-threatening infection
  • Grade 5 = death resulting from infection
Time Frame Transplantation to 40 Weeks Post Transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
All transplanted participants.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
Overall Number of Participants Analyzed 6 9 0 0
Measure Type: Number
Unit of Measure: Percent of Participants
0 11.1
3.Primary Outcome
Title Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s)
Hide Description

The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):

  • Grade 3 wound complications are defined as "Hernia without evidence of strangulation; fascial disruption/dehiscence; primary wound closure or revision by operative intervention indicated"
  • Grade 4 complications are defined as "Hernia with evidence of strangulation; major reconstruction flap, grafting, resection, or amputation indicated"
Time Frame Transplantation to 40 Weeks Post Transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
All transplanted participants.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
Overall Number of Participants Analyzed 6 9 0 0
Measure Type: Number
Unit of Measure: Percent of Participants
0 0
4.Primary Outcome
Title Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia
Hide Description

The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):

  • Grade 1 = mild AE
  • Grade 2 = moderate AE
  • Grade 3 = severe and undesirable AE
  • Grade 4 = life-threatening or disabling AE
  • Grade 5 = death
Time Frame Transplantation to 40 Weeks Post Transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
All transplanted participants.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
Overall Number of Participants Analyzed 6 9 0 0
Measure Type: Number
Unit of Measure: Percent of Participants
Anemia 66.7 22.2
Neutropenia 16.7 0
Thrombocytopenia 16.7 0
5.Primary Outcome
Title Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion
Hide Description

AEs classified by the site investigator/clinician as possibly or definitely related to the study treatment, the Donor Alloantigen Reactive Tregs (darTregs) infusion. These AEs include:

  • infusion reaction
  • Grade 3 or higher cytokine release syndrome (Reference: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009) grading criteria
  • malignant cellular transformation.
Time Frame Transplantation to 40 Weeks Post Transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Limited to participants that received darTreg infusion (N=1 study participant).
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
Overall Number of Participants Analyzed 0 1 0 0
Measure Type: Number
Unit of Measure: Percent of Participants
0
Time Frame 40 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Participants received Thymoglobulin® +EVR IS but will not receive darTregs Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/6 (66.67%)      4/9 (44.44%)    
Blood and lymphatic system disorders     
Anaemia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Iron deficiency anaemia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Neutropenia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Thrombocytopenia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Ileus  1  1/6 (16.67%)  1 1/9 (11.11%)  1
Intestinal obstruction  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Nausea  1  0/6 (0.00%)  0 0/9 (0.00%)  0
General disorders     
Chest pain  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Fatigue  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Influenza like illness  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Oedema  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Pyrexia  1  0/6 (0.00%)  0 2/9 (22.22%)  2
Hepatobiliary disorders     
Biliary ischaemia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Portal vein thrombosis  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Immune system disorders     
Liver transplant rejection  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Infections and infestations     
Gastroenteritis  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Tooth infection  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Upper respiratory tract infection  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Viral infection  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Wound infection  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Injury, poisoning and procedural complications     
Infusion related reaction  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Post procedural haemorrhage  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Postoperative ileus  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Blood alkaline phosphatase increased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Blood creatinine increased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Lymphocyte count decreased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Platelet count decreased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Weight decreased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
White blood cell count decreased  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Metabolism and nutrition disorders     
Failure to thrive  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Hyperkalaemia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Hypomagnesaemia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders     
Headache  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Psychiatric disorders     
Insomnia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Renal and urinary disorders     
Calculus urinary  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Proteinuria  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Renal failure acute  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypocapnia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Pleural effusion  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders     
Eczema  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Rash  1  0/6 (0.00%)  0 0/9 (0.00%)  0
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      6/9 (66.67%)    
Blood and lymphatic system disorders     
Anaemia  1  4/6 (66.67%)  4 1/9 (11.11%)  1
Iron deficiency anaemia  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Neutropenia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Thrombocytopenia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Ileus  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Intestinal obstruction  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Nausea  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Inguinal hernia  1  0/6 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Chest pain  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Fatigue  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Influenza like illness  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Oedema  1  1/6 (16.67%)  1 1/9 (11.11%)  1
Pyrexia  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Hepatobiliary disorders     
Biliary ischaemia  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Portal vein thrombosis  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Immune system disorders     
Liver transplant rejection  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations     
Gastroenteritis  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Tooth infection  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Upper respiratory tract infection  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Viral infection  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Wound infection  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Injury, poisoning and procedural complications     
Infusion related reaction  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Post procedural haemorrhage  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Postoperative ileus  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  2/6 (33.33%)  2 0/9 (0.00%)  0
Blood alkaline phosphatase increased  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Blood creatinine increased  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Gamma-glutamyltransferase increased  1  3/6 (50.00%)  3 0/9 (0.00%)  0
Lymphocyte count decreased  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Platelet count decreased  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Weight decreased  1  0/6 (0.00%)  0 1/9 (11.11%)  1
White blood cell count decreased  1  1/6 (16.67%)  1 1/9 (11.11%)  1
Metabolism and nutrition disorders     
Failure to thrive  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Hyperkalaemia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Hypomagnesaemia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Nervous system disorders     
Headache  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders     
Insomnia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Renal and urinary disorders     
Calculus urinary  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Proteinuria  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Renal failure acute  1  0/6 (0.00%)  0 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypocapnia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Pleural effusion  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders     
Eczema  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Rash  1  1/6 (16.67%)  1 0/9 (0.00%)  0
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Enrollment was terminated due to several factors:high number of ineligible subjects, slow enrollment, and manufacturing difficulties within the constraints of the funding period.
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
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02188719    
Other Study ID Numbers: DAIT RTB-002
R34AI095135 ( U.S. NIH Grant/Contract )
U01AI110658 ( U.S. NIH Grant/Contract )
NIAID CRMS ID#: 20182 ( Other Identifier: DAIT NIAID )
First Submitted: July 10, 2014
First Posted: July 14, 2014
Results First Submitted: June 16, 2020
Results First Posted: July 20, 2020
Last Update Posted: September 22, 2020