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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
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BB3, 4 Daily Doses Placebo; 4 Daily Doses
Hide Arm/Group Description 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: Normal saline; Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
Period Title: Overall Study
Started 3 2
Complete Study Treatment 1 2
Completed 0 2
Not Completed 3 0
Arm/Group Title BB3, 4 Daily Doses Placebo Total
Hide Arm/Group Description BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days Normal saline. Daily intravenous administration for four (4) days. Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 2 participants 5 participants
61
(50 to 75)
57.5
(46 to 69)
59
(46 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
1
  33.3%
0
   0.0%
1
  20.0%
Male
2
  66.7%
2
 100.0%
4
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 2 participants 5 participants
3 2 5
1.Primary Outcome
Title Evaluation of Reduction in Infarct Size
Hide Description Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage
Time Frame 6 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Five subjects were enrolled into the study; 3 subjects were randomized to BB3 and 2 subjects to placebo. Of the 3 subjects randomized to BB3, 1 completed study treatment; all three subjects discontinued the study prematurely. The two subjects randomized to placebo completed study treatment and neither discontinued the study prematurely.
Arm/Group Title BB3, 4 Daily Doses Placebo, 4 Daily Doses
Hide Arm/Group Description:
BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
Normal saline. Daily intravenous administration for four (4) days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Evaluation of the Degree of Late Ventricular Remodeling
Hide Description Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).
Time Frame 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in CK-MB and Troponin
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in BNP Levels
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in Symptoms and Clinical Signs of CHF
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography
Hide Description [Not Specified]
Time Frame 1 and 6 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain
Hide Description [Not Specified]
Time Frame 1 and 6 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Frequency of MACE
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Frequency of New Onset CHF Through 6 Months
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Number of Hospitalizations for CHF Through 6 Months
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Frequency of AE, SAEs
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Frequency of MACCE
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
16.Secondary Outcome
Title All-cause Mortality
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Change From Baseline eCrCl
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Change in Body Weight
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Symptoms and Clinical Signs of CHF
Hide Description Symptoms and clinical signs of CHF measured by NYHA classification
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BB3 Small Molecule Mimetic of Hepatocyte Growth Factor Placebo
Hide Arm/Group Description

small molecule mimetic of hepatocyte growth factor/scatter factor

BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days

Normal saline

Placebo: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.

All-Cause Mortality
BB3 Small Molecule Mimetic of Hepatocyte Growth Factor Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BB3 Small Molecule Mimetic of Hepatocyte Growth Factor Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BB3 Small Molecule Mimetic of Hepatocyte Growth Factor Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   1/2 (50.00%) 
Cardiac disorders     
bradycardia  1/3 (33.33%)  0/2 (0.00%) 
ventricular tachycardia  1/3 (33.33%)  0/2 (0.00%) 
Ear and labyrinth disorders     
tinnitus  0/3 (0.00%)  1/2 (50.00%) 
Gastrointestinal disorders     
nausea and vomiting  1/3 (33.33%)  0/2 (0.00%) 
General disorders     
headache  0/3 (0.00%)  1/2 (50.00%) 
hyperhidrosis  1/3 (33.33%)  0/2 (0.00%) 
dizziness  1/3 (33.33%)  0/2 (0.00%) 
fatigue  0/3 (0.00%)  1/2 (50.00%) 
Infections and infestations     
sinusitis  0/3 (0.00%)  1/2 (50.00%) 
Surgical and medical procedures     
infusion site pain  1/3 (33.33%)  0/2 (0.00%) 
Vascular disorders     
hypotension  1/3 (33.33%)  0/2 (0.00%) 
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.
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.
Results Point of Contact
Name/Title: Dr. Joesph Brennan
Organization: Yale University Medical Center
Phone: (203) 483-8300
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