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Safety and Efficacy of Sodium Nitrite in Sickle Cell Disease

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborator:
Hope Pharmaceuticals
Information provided by (Responsible Party):
Thomas Coates, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01033227
First received: December 15, 2009
Last updated: December 15, 2016
Last verified: October 2016
Results First Received: April 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sickle Cell Disease
Intervention: Drug: sodium nitrite injection, usp

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited for the study during regular clinic visits.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once consent signed subjects would not be randomized into the treatment arm until (if or when) they had their admission to the hospital for vaso-occlusive crisis (VOC).

Reporting Groups
  Description
No Drug This group did not receive anything additional in the no drug arm. The treatment group received the study drug and the non treatment group received no drug.
Sodium Nitrite Injection, USP

Administration if sodium nitrite injection, USP

sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose).


Participant Flow:   Overall Study
    No Drug   Sodium Nitrite Injection, USP
STARTED   3   2 
COMPLETED   3   2 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data was collected but never organized/analyzed due to early termination of the study.

Reporting Groups
  Description
No Drug No text entered.
Sodium Nitrite Injection, USP

Administration if sodium nitrite injection, USP

sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose).

Total Total of all reporting groups

Baseline Measures
   No Drug   Sodium Nitrite Injection, USP   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   2   5 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      3 100.0%      1  50.0%      4  80.0% 
Between 18 and 65 years      0   0.0%      1  50.0%      1  20.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 16 
 (15 to 17) 
 15.5 
 (11 to 20) 
 16 
 (11 to 20) 
Gender 
[Units: Participants]
Count of Participants
     
Female      3 100.0%      2 100.0%      5 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   3   2   5 
Sickle Cell Disease hb SS 
[Units: Participants]
Count of Participants
 3   1   4 
Sbeta+thalassemia 
[Units: Participants]
Count of Participants
 1   0   1 


  Outcome Measures

1.  Primary:   48 Hour Sodium Nitrite Infusion is Safe as Determined by no Adverse Events   [ Time Frame: 48 hours from start of infusion ]

2.  Secondary:   Secondary End Point   [ Time Frame: 48 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Thomas Coates
Organization: Children's Hospital Los Angeles
phone: 323 361 3841
e-mail: TCoates@chla.usc.edu


Publications:


Responsible Party: Thomas Coates, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01033227     History of Changes
Other Study ID Numbers: SN-SC-02-01
Study First Received: December 15, 2009
Results First Received: April 13, 2016
Last Updated: December 15, 2016