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Study to Evaluate the Safety and Activity of BB3 to Treat Heart Attack

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ClinicalTrials.gov Identifier: NCT01539590
Recruitment Status : Terminated
First Posted : February 27, 2012
Results First Posted : November 4, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Angion Biomedica Corp

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Myocardial Infarction
Interventions: Drug: BB3
Drug: Normal saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
BB3, 4 Daily Doses BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days ; 10 to 12 minutes; small molecule mimetic of hepatocyte growth factor
Placebo; 4 Daily Doses Placebo: Normal saline; Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.

Participant Flow:   Overall Study
    BB3, 4 Daily Doses   Placebo; 4 Daily Doses
STARTED   3   2 
Complete Study Treatment   1   2 
COMPLETED   0   2 
NOT COMPLETED   3   0 



  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
BB3, 4 Daily Doses BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
Placebo Normal saline. Daily intravenous administration for four (4) days.
Total Total of all reporting groups

Baseline Measures
   BB3, 4 Daily Doses   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   2   5 
Age 
[Units: Years]
Mean (Full Range)
 61 
 (50 to 75) 
 57.5 
 (46 to 69) 
 59 
 (46 to 75) 
Gender 
[Units: Participants]
     
Female   1   0   1 
Male   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   3   2   5 


  Outcome Measures

1.  Primary:   Evaluation of Reduction in Infarct Size   [ Time Frame: 6 month ]

2.  Primary:   Evaluation of the Degree of Late Ventricular Remodeling   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Change in CK-MB and Troponin   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in BNP Levels   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in Symptoms and Clinical Signs of CHF   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography   [ Time Frame: 1 and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain   [ Time Frame: 1 and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Frequency of MACE   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Frequency of New Onset CHF Through 6 Months   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Number of Hospitalizations for CHF Through 6 Months   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Secondary:   Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Secondary:   Frequency of AE, SAEs   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Secondary:   Frequency of MACCE   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

16.  Secondary:   All-cause Mortality   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

17.  Secondary:   Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

18.  Secondary:   Change From Baseline eCrCl   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

19.  Secondary:   Change in Body Weight   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

20.  Secondary:   Symptoms and Clinical Signs of CHF   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
Five subjects were enrolled into the study; 3 subjects were randomized to BB3 and 2 subjects to placebo. All the 3 subjects randomized to BB3 discontinued the study prematurely. The 2 subjects randomized to placebo completed study treatment.


  More Information

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 less than or equal to 60 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: Dr. Joesph Brennan
Organization: Yale University Medical Center
phone: (203) 483-8300
e-mail: Brennan.Joesph@yale.edu



Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT01539590     History of Changes
Other Study ID Numbers: 001-10
5R44HL091699 ( U.S. NIH Grant/Contract )
First Submitted: February 22, 2012
First Posted: February 27, 2012
Results First Submitted: October 29, 2014
Results First Posted: November 4, 2014
Last Update Posted: November 21, 2014