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Trial record 1 of 1 for:    NCT03219372
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Pravastatin Intervention to Delay Hepatocellular Carcinoma Recurrence

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ClinicalTrials.gov Identifier: NCT03219372
Recruitment Status : Terminated (Study discontinued due to low accrual.)
First Posted : July 17, 2017
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shehnaz Hussain, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Hepatocellular Carcinoma
Liver Cirrhoses
Interventions Drug: Pravastatin Pill
Drug: Placebo Oral Tablet
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Pravastatin Pill Placebo Oral Tablet Total
Hide Arm/Group Description

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
0 participants enrolled in placebo group due to 1 total participant enrollment in pravastatin group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
>=65 years
1
 100.0%
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
1
 100.0%
1
 100.0%
White
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Time to Recurrence
Hide Description

Mean difference in time (in months) from baseline (study visit 1) to first hepatocellular cancer (HCC) recurrence or HCC death within 12 months following treatment initiation for subjects randomized to pravastatin versus subjects randomized to placebo.

- HCC recurrence will be confirmed by central expert independent radiographic review.

Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Recurrence Free Survival
Hide Description

Mean difference in time (in months) from baseline (study visit 1) to first occurrence of a documented hepatocellular cancer (HCC) recurrence within 12 months following treatment initiation for subjects randomized to pravastatin versus subjects randomized to placebo.

- HCC recurrence will be confirmed by central expert independent radiographic review.

Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Mean difference in time (in months) from baseline (study visit 1) to death (for any reason) within 12 months following treatment initiation for subjects randomized to pravastatin versus subjects randomized to placebo.
Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Waitlist Drop-off
Hide Description Mean difference in time from baseline (study visit 1) to liver transplant waitlist drop-off within 12 months following treatment initiation for subjects randomized to pravastatin versus subjects randomized to placebo.
Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Liver Stiffness
Hide Description Mean difference in mean change in liver stiffness (as measured by MRE or FibroScan) between baseline (study visit 1) and 12 months (study visit 6) for subjects randomized to pravastatin versus subjects randomized to placebo.
Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Liver Fat Fraction
Hide Description Mean difference in within-person change in liver fat fraction (as measured by MRE) between baseline (study visit 1) and 12 months (study visit 6) for subjects randomized to pravastatin versus subjects randomized to placebo.
Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Serum Biomarkers of Monocyte/Macrophage and Stellate Cell Activation
Hide Description Mean difference in serum biomarkers including cytokines, chemokines, soluble receptors, and proteins (eg. IL6, TNFα, sTNFRII, IL18BP, sCD163, IL10, IL17, IL-8, CCL17, TGFβ) from baseline (study visit 1) to 12 months (study visit 6) for subjects randomized to pravastatin versus subjects randomized to placebo.
Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Levels of Liver Tissue Markers Related to HCC
Hide Description Mean difference in liver tissue markers related to HCC including those in the Wnt/β-catenin pathway (eg. β-catenin, glutamine synthetase) from baseline (study visit 1) to 12 months (study visit 6) for subjects randomized to pravastatin versus subjects randomized to placebo.
Time Frame 12 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description:

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected over the 2-month* intervention period (one patient and early withdrawal at Visit 2) and within 90 days after the last administration of the study drug. *Scheduled intervention period for this study was 12 months with 6 study visits.
Adverse Event Reporting Description Regular investigator assessment, regular laboratory testing, self-reporting.
 
Arm/Group Title Pravastatin Pill Placebo Oral Tablet
Hide Arm/Group Description

Pravastatin 40 mg, daily for 12 months

Pravastatin, a lipid-lowering agent, is a derivative of ML236B (compactin), which was identified in a fungus called Penicillium citrinum in the 1970s. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Placebo identical in color, consistency, and appearance to pravastatin 40 mg, daily for 12 months

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

All-Cause Mortality
Pravastatin Pill Placebo Oral Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/0    
Hide Serious Adverse Events
Pravastatin Pill Placebo Oral Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/0    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pravastatin Pill Placebo Oral Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
General disorders     
Fatigue  1  1/1 (100.00%)  1 0/0  0
1
Term from vocabulary, CTCAE Version 5.0
Indicates events were collected by systematic assessment
Accrual fell well below target. One subject was randomized to the study and withdrew prior to completion. Outcome measures were not analyzed due to insufficient accrual.
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: Shehnaz K. Hussain, PhD, ScM
Organization: Cedars Sinai Medical Center
Phone: 310-429-9859
EMail: Shehnaz.Hussain@cshs.org
Layout table for additonal information
Responsible Party: Shehnaz Hussain, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03219372    
Other Study ID Numbers: IIT2017-08-HUSSAIN-STATLV
1R01CA218486-01 ( U.S. NIH Grant/Contract )
First Submitted: July 13, 2017
First Posted: July 17, 2017
Results First Submitted: October 21, 2020
Results First Posted: January 22, 2021
Last Update Posted: January 22, 2021