Trial Outcomes & Findings for Study to Evaluate the Safety and Activity of BB3 to Treat Heart Attack (NCT NCT01539590)

Results Overview

Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

6 month

Results posted on

2014-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3	2
Overall Study Complete Study Treatment	1	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BB3, 4 Daily Doses n=3 Participants BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days	Placebo n=2 Participants Normal saline. Daily intravenous administration for four (4) days.	Total n=5 Participants Total of all reporting groups
Age, Continuous	61 years n=93 Participants	57.5 years n=4 Participants	59 years n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 month

Population: 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.

Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 and 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 and 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Symptoms and clinical signs of CHF measured by NYHA classification

Outcome measures

Outcome data not reported

Adverse Events

BB3 Small Molecule Mimetic of Hepatocyte Growth Factor

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BB3 Small Molecule Mimetic of Hepatocyte Growth Factor n=3 participants at risk small molecule mimetic of hepatocyte growth factor/scatter factor BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days	Placebo n=2 participants at risk Normal saline Placebo: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
Cardiac disorders bradycardia	33.3% 1/3	0.00% 0/2
Vascular disorders hypotension	33.3% 1/3	0.00% 0/2
General disorders headache	0.00% 0/3	50.0% 1/2
General disorders hyperhidrosis	33.3% 1/3	0.00% 0/2
Gastrointestinal disorders nausea and vomiting	33.3% 1/3	0.00% 0/2
Cardiac disorders ventricular tachycardia	33.3% 1/3	0.00% 0/2
General disorders dizziness	33.3% 1/3	0.00% 0/2
Surgical and medical procedures infusion site pain	33.3% 1/3	0.00% 0/2
Ear and labyrinth disorders tinnitus	0.00% 0/3	50.0% 1/2
Infections and infestations sinusitis	0.00% 0/3	50.0% 1/2
General disorders fatigue	0.00% 0/3	50.0% 1/2

Additional Information

Dr. Joesph Brennan

Yale University Medical Center

Phone: (203) 483-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60