Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)

This study has been completed.
Sponsor:
Collaborators:
Thoratec Corporation
Novartis
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01707225
First received: October 11, 2012
Last updated: December 7, 2015
Last verified: December 2015
Results First Received: December 7, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Bleeding
Intervention: Drug: Octreotide LAR Depot

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Octreotide LAR Depot

Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.

Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study.


Participant Flow:   Overall Study
    Octreotide LAR Depot  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     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.
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Reporting Groups
  Description
Octreotide LAR Depot

Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.

Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study.


Baseline Measures
    Octreotide LAR Depot  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     2  
Gender  
[units: participants]
 
Female     2  
Male     8  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     10  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     7  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   The Primary Specific Aim is to Determine the Safety of Octreotide LAR in Patients With a LVAD.   [ Time Frame: 24 weeks ]

2.  Secondary:   Our Key Secondary Outcomes Will Focus on Study Drug Efficacy. Patient Experience of the Following Will be Assessed: Need for Blood Transfusion Hospital Admission for GI Bleed   [ Time Frame: 24 weeks ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rajiv Malhotra, DO
Organization: Virginia Commonwealth University
phone: 804-828-9071
e-mail: rajiv.malhotra@vcuhealth.org



Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01707225     History of Changes
Other Study ID Numbers: HM14516
Study First Received: October 11, 2012
Results First Received: December 7, 2015
Last Updated: December 7, 2015
Health Authority: United States: Food and Drug Administration