Use of F-652 in Patients With Alcoholic Hepatitis (TREAT 008)

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ClinicalTrials.gov Identifier: NCT02655510

Recruitment Status : Completed

First Posted : January 14, 2016

Results First Posted : September 9, 2019

Last Update Posted : September 9, 2019

Sponsor:

Collaborators:

Indiana University

Virginia Commonwealth University

Hennepin County Medical Center, Minneapolis

Information provided by (Responsible Party):

Vijay Shah, M.D., Mayo Clinic

Study Type	Interventional
Study Design	Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Alcoholic Hepatitis
Intervention	Drug: F-652
Enrollment	18

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Period 1: F-652 10 μg/kg	Period 2: F-652 30 μg/kg	Period 3: F-652 45 μg/kg
Arm/Group Description	Participants will receive 10 μg/kg ...	Participants will receive 30 μg/kg ...	Participants will receive 45 μg/kg ...
Arm/Group Description	Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.	Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.	Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
Period Title: Overall Study
Started	6	6	6
Completed	6	6	6
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Period 1: F-652 10 μg/kg	Period 2: F-652 30 μg/kg	Period 3: F-652 45 μg/kg	Total
Arm/Group Description		Participants will receive 10 μg/kg ...	Participants will receive 30 μg/kg ...	Participants will receive 45 μg/kg ...	Total of all reporting groups
Arm/Group Description		Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.	Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion	Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.	Total of all reporting groups
Overall Number of Baseline Participants		6	6	6	18
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	6 participants	6 participants	6 participants	18 participants
		46.8 (6.9)	50.5 (12.0)	50.3 (11.3)	49.1 (9.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	6 participants	18 participants
	Female	2 33.3%	2 33.3%	2 33.3%	6 33.3%
	Male	4 66.7%	4 66.7%	4 66.7%	12 66.7%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	6 participants	18 participants
	American Indian or Alaska Native	1 16.7%	0 0.0%	0 0.0%	1 5.6%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	5 83.3%	6 100.0%	6 100.0%	17 94.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	6 participants	6 participants	6 participants	18 participants
United States		6	6	6	18
Alcohol Consumption by MELD grouping ^[1] [2] Mean (Standard Deviation) Unit of measure: Grams per day
MELD 11-20	Number Analyzed	3 participants	3 participants	3 participants	9 participants
MELD 11-20		143.3 (75.0)	151.3 (28.8)	186.6 (88.9)	160.4 (63.1)
MELD 21-28	Number Analyzed	3 participants	3 participants	3 participants	9 participants
MELD 21-28		181.3 (140.0)	212.6 (141.7)	57.3 (28.0)	150.4 (123.2)
		[1] Measure Description: Amount of alcohol consumed on a daily basis measured in grams. A MELD score (model for end state liver disease) ranks the degree of sickness the degree to which a liver transplant is needed. The higher the number the more severe the sickness and the more urgent need for a liver transplant. [2] Measure Analysis Population Description: The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
Hospitalized at screening by MELD grouping ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
MELD 11-20	Number Analyzed	3 participants	3 participants	3 participants	9 participants
MELD 11-20		3 100.0%	3 100.0%	2 66.7%	8 88.9%
MELD 21-28	Number Analyzed	3 participants	3 participants	3 participants	9 participants
MELD 21-28		1 33.3%	1 33.3%	3 100.0%	5 55.6%
		[1] Measure Description: Number of subjects hospitalized at screening visit. A MELD score (model for end state liver disease) ranks the degree of sickness the degree to which a liver transplant is needed. The higher the number the more severe the sickness and the more urgent need for a liver transplant. [2] Measure Analysis Population Description: The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.

Outcome Measures

1.Primary Outcome


Title	The Number of Subjects With Unexpected Serious Adverse Events.
Description	The count of subjects who experience serious adverse events
Description	The count of subjects who experience serious adverse events
Time Frame	From day 1 up to 42 days following administration of last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Period 1: F-652 10 μg/kg	Period 2: F-652 30 μg/kg	Period 3: F-652 45 μg/kg
Arm/Group Description:	Participants will receive 10 μg/kg ...	Participants will receive 30 μg/kg ...	Participants will receive 45 μg/kg ...
Arm/Group Description:	Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.	Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.	Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
Overall Number of Participants Analyzed	6	6	6
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Period 1: F-652 10 μg/kg		Period 2: F-652 30 μg/kg		Period 3: F-652 45 μg/kg
Arm/Group Description	Participants will receive 10 μg/kg ...		Participants will receive 30 μg/kg ...		Participants will receive 45 μg/kg ...
Arm/Group Description	Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.		Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.		Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
All-Cause Mortality
	Period 1: F-652 10 μg/kg		Period 2: F-652 30 μg/kg		Period 3: F-652 45 μg/kg
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/6 (0.00%)		1/6 (16.67%)		0/6 (0.00%)
Serious Adverse Events Serious Adverse Events
	Period 1: F-652 10 μg/kg		Period 2: F-652 30 μg/kg		Period 3: F-652 45 μg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0.00%)		0/6 (0.00%)		0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Period 1: F-652 10 μg/kg		Period 2: F-652 30 μg/kg		Period 3: F-652 45 μg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/6 (33.33%)		5/6 (83.33%)		4/6 (66.67%)
Cardiac disorders
Arrhythmia ^†	0/6 (0.00%)	0	0/6 (0.00%)	0	1/6 (16.67%)	1
Hypertension ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Atrioventricular block ^†	0/6 (0.00%)	0	0/6 (0.00%)	0	1/6 (16.67%)	1
Gastrointestinal disorders
Diarrhea ^†	0/6 (0.00%)	0	0/6 (0.00%)	0	1/6 (16.67%)	1
Constipation ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
General disorders
Fever ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Nausea ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Tremors ^†	1/6 (16.67%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0
Muscle Weakness ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Increased body temperature ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Thrombocytosis ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Hepatobiliary disorders
Hyperbilirubinaemia ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Investigations
Leukocytosis ^†	0/6 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0
Skin and subcutaneous tissue disorders
Pruritus ^†	0/6 (0.00%)	0	2/6 (33.33%)	3	1/6 (16.67%)	1
Rash ^†	1/6 (16.67%)	1	0/6 (0.00%)	0	1/6 (16.67%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Vijay Shah, M.D.
Organization:	Mayo Clinic
Phone:	507-284-3917
EMail:	Shah.Vijay@mayo.edu

Layout table for additonal information

Responsible Party:	Vijay Shah, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT02655510
Other Study ID Numbers:	15-003249
First Submitted:	January 7, 2016
First Posted:	January 14, 2016
Results First Submitted:	June 11, 2019
Results First Posted:	September 9, 2019
Last Update Posted:	September 9, 2019

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