Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Cangene Corporation
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00998426
First received: October 7, 2009
Last updated: August 26, 2015
Last verified: April 2015
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Hepatitis B
Interventions: Procedure: glucose monitoring before and after HepaGam B administration
Biological: HepaGam B (Hepatitis B Immune Globulin (HBIG))

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult OLT recipients receiving maintenance HBIG therapy were recruited from the inpatient liver transplant service.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Study Participants

Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.

Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring


Participant Flow:   Overall Study
    All Study Participants  
STARTED     5  
Blood Glucose Monitoring     5  
COMPLETED     5  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
All Study Participants

Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.

Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose ). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring


Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  48  (8)  
Gender  
[units: participants]
 
Female     2  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     5  
adult OLT recipients [1]
[units: participants]
  5  
[1] This is a nonrandomized, prospective study evaluating patients receiving maintenance HBIG therapy over 3 months post liver transplantation. Blood glucose levels in each subject were analyzed by GSPOC and GNSPOC devices at specific times around HBIG administration



  Outcome Measures

1.  Primary:   Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection   [ Time Frame: Pre-dose, immediately following, 60 min and 120 min after injection ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide 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: Kirti Shetty, MD
Organization: Johns Hopkins Medicine
phone: 202 660 5555
e-mail: kshetty1@jhmi.edu



Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00998426     History of Changes
Other Study ID Numbers: 2009-337
Study First Received: October 7, 2009
Results First Received: February 9, 2015
Last Updated: August 26, 2015
Health Authority: United States: Institutional Review Board