Trial Outcomes & Findings for Pravastatin Intervention to Delay Hepatocellular Carcinoma Recurrence (NCT NCT03219372)
NCT ID: NCT03219372
Last Updated: 2021-01-22
Results Overview
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.
TERMINATED
PHASE2
1 participants
12 months from baseline
2021-01-22
Participant Flow
Participant milestones
| Measure |
Pravastatin Pill
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 Oral Tablet
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 Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pravastatin Pill
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 Oral Tablet
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 Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Pravastatin Intervention to Delay Hepatocellular Carcinoma Recurrence
Baseline characteristics by cohort
| Measure |
Pravastatin Pill
n=1 Participants
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 Oral Tablet
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
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: As accrual fell far below target, for associated privacy considerations related to the potential for participant re-identification, data are not reported.
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.
Outcome measures
Outcome data not reported
Adverse Events
Pravastatin Pill
Placebo Oral Tablet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pravastatin Pill
n=1 participants at risk
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 Oral Tablet
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.
|
|---|---|---|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • 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.
Regular investigator assessment, regular laboratory testing, self-reporting.
|
—
0/0 • 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.
Regular investigator assessment, regular laboratory testing, self-reporting.
|
Additional Information
Shehnaz K. Hussain, PhD, ScM
Cedars Sinai Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place