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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
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
Hide 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
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
Hide 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
Hide 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
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
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
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
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
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.
1.Primary Outcome
Title The Number of Subjects With Unexpected Serious Adverse Events.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
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
Hide 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%)    
Hide 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%)    
Hide 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
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