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Trial record 10 of 24 for:    RILONACEPT OR ARCALYST OR IL-1 TRAP OR INTERLEUKIN-1 TRAP

A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903798
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : October 25, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
University of Southern California
Los Angeles Biomedical Research Institute
VA Long Beach Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Timothy Morgan, MD, Southern California Institute for Research and Education

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alcoholic Hepatitis
Interventions Drug: Mycophenolate mofetil
Drug: Prednisolone
Drug: Rilonacept
Enrollment 4
Recruitment Details 4 participants were randomized. 3 in the standard of care (with Prednisolone) and 1 in mycophenolate + prednisolone arm. Out of 3 randomized to the SOC arm, 2 had a Lille score of <.45 and one had a Lille score of >.45. The participant who was randomized to mycophenolate + prednisolone had a Lille score of >.45.
Pre-assignment Details  
Arm/Group Title Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45)
Hide Arm/Group Description

Continue prednisolone 40 mg/day (current standard of care) for 21 days.

Prednisolone: Corticosteroid

Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).

Rilonacept: Interleukin-1 blocker

Prednisolone: Corticosteroid

Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)

Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).

Mycophenolate mofetil: Immunosuppressive agent

Prednisolone: Corticosteroid

Period Title: Overall Study
Started 2 0 1 1
Completed 2 0 1 1
Not Completed 0 0 0 0
Arm/Group Title Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45) Total
Hide Arm/Group Description

Continue prednisolone 40 mg/day (current standard of care) for 21 days.

Prednisolone: Corticosteroid

Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).

Rilonacept: Interleukin-1 blocker

Prednisolone: Corticosteroid

Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)

Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).

Mycophenolate mofetil: Immunosuppressive agent

Prednisolone: Corticosteroid

Total of all reporting groups
Overall Number of Baseline Participants 2 0 1 1 4
Hide Baseline Analysis Population Description
No participant was randomized to the Rilonacept + Prednisolone
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 1 participants 1 participants 4 participants
<=18 years
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
0
1
 100.0%
0
   0.0%
3
  75.0%
>=65 years
0
   0.0%
0
0
   0.0%
1
 100.0%
1
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 0 participants 1 participants 1 participants 4 participants
45.6  (9.7) 71.2  (0) 58  (0) 52  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 1 participants 1 participants 4 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 1 participants 1 participants 4 participants
Hispanic or Latino
1
  50.0%
0
   0.0%
0
   0.0%
1
  25.0%
Not Hispanic or Latino
1
  50.0%
1
 100.0%
1
 100.0%
3
  75.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 1 participants 1 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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%
1
 100.0%
1
  25.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
1
 100.0%
0
   0.0%
3
  75.0%
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 2 participants 0 participants 1 participants 1 participants 4 participants
2 1 1 4
1.Primary Outcome
Title Survival at Day 29 of the Assigned Treatment
Hide Description

To determine whether treatment with prednisolone + mycophenolate mofetil is better than standard of care treatment among patients with alcoholic hepatitis who fail to respond to 1 week of prednisolone (i.e., Lille score of ≥0.45). Primary outcome is survival at Day 29.

All study participants received the Standard of care (prednisolone) with or without experimental drug at Day 1 (based on randomization). Response to the treatment was determined at Day 8. Data was collected for both responders and non-responders.

Time Frame Day 8 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
There was no participant randomized to rilonocept +prednisolone arm
Arm/Group Title Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45)
Hide Arm/Group Description:

Continue prednisolone 40 mg/day (current standard of care) for 21 days.

Prednisolone: Corticosteroid

Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).

Rilonacept: Interleukin-1 blocker

Prednisolone: Corticosteroid

Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)

Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).

Mycophenolate mofetil: Immunosuppressive agent

Prednisolone: Corticosteroid

Overall Number of Participants Analyzed 2 0 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
0
1
 100.0%
1
 100.0%
2.Secondary Outcome
Title Number of Patients Reported Ascites
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
No patient was randomized to Rilonacept +prednisolone arm
Arm/Group Title Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45)
Hide Arm/Group Description:

Continue prednisolone 40 mg/day (current standard of care) for 21 days.

Prednisolone: Corticosteroid

Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).

Rilonacept: Interleukin-1 blocker

Prednisolone: Corticosteroid

Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)

Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).

Mycophenolate mofetil: Immunosuppressive agent

Prednisolone: Corticosteroid

Overall Number of Participants Analyzed 2 0 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
1
 100.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45)
Hide Arm/Group Description

Continue prednisolone 40 mg/day (current standard of care) for 21 days.

Prednisolone: Corticosteroid

Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).

Rilonacept: Interleukin-1 blocker

Prednisolone: Corticosteroid

Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)

Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).

Mycophenolate mofetil: Immunosuppressive agent

Prednisolone: Corticosteroid

All-Cause Mortality
Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/0      1/1 (100.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/0      1/1 (100.00%)      1/1 (100.00%)    
Infections and infestations         
Urinary Tract Infection   0/2 (0.00%)  0 0/0  0 1/1 (100.00%)  1 0/1 (0.00%)  0
Nervous system disorders         
Hepatic Encephalopathy   0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continue Prednisolone (Lille <0.45) Rilonacept + Prednisolone (Lille <0.45) Standard of Care (Lille ≥ 0.45) Mycophenolate + Prednisolone (Lille ≥ 0.45)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/0      1/1 (100.00%)      1/1 (100.00%)    
Gastrointestinal disorders         
ascites   0/2 (0.00%)  0 0/0  0 1/1 (100.00%)  1 0/1 (0.00%)  0
Rectal Bleeding *  0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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: Executive Director, Southern California Institute for Research and Education
Organization: SCIRE
Phone: 562-826-8000 ext 5747
Responsible Party: Timothy Morgan, MD, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01903798     History of Changes
Other Study ID Numbers: SCAHC Clinical Trial
1U01AA021886 ( U.S. NIH Grant/Contract )
First Submitted: July 16, 2013
First Posted: July 19, 2013
Results First Submitted: September 20, 2018
Results First Posted: October 25, 2018
Last Update Posted: January 14, 2019