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A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02314689
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : March 7, 2016
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Suvankar Majumdar, University of Mississippi Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: Intravenous (IV) citrulline
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravenous (IV) Citrulline
Hide Arm/Group Description Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
Period Title: Overall Study
Started 4
Completed 4 [1]
Not Completed 0
[1]
Target citrulline level reached with first 4 subjects enrolled at initial IV citrulline of 20 mg/kg
Arm/Group Title Intravenous (IV) Citrulline
Hide Arm/Group Description Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
22.8
(21 to 25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Number of Participants With Grade 2 or Higher Adverse Event According to NCI Criteria
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Citrulline
Hide Arm/Group Description:

IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.

Intravenous (IV) citrulline

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
0
Time Frame 1 week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous (IV) Citrulline
Hide Arm/Group Description Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
All-Cause Mortality
Intravenous (IV) Citrulline
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Intravenous (IV) Citrulline
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intravenous (IV) Citrulline
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Vascular disorders   
Greater than 20% drop in blood pressure * [1]  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
1 out of the 4 patients dropped the DBS greater than 20% from baseline but maintained normal systolic BP, heart rate and other vital signs. Participant did not require any intervention. Case was reviewed by the DSMB and deemed a grade 1 adverse event
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: Suvankar Majumdar MD
Organization: University of Mississippi Medical Center
Phone: 6019845220
EMail: smajumdar@umc.edu
Layout table for additonal information
Responsible Party: Suvankar Majumdar, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT02314689    
Other Study ID Numbers: SCD-124700.
First Submitted: December 5, 2014
First Posted: December 11, 2014
Results First Submitted: December 9, 2015
Results First Posted: March 7, 2016
Last Update Posted: September 3, 2019