Trial Outcomes & Findings for Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C (NCT NCT02971033)

Last Updated: 2022-06-06

Results Overview

Participants will have their HCV-RNA measured in international unit per milliliter at baseline and 8 weeks. HCV RNA international unit per milliliter ranges from 0 to infinity, with higher levels indicating HCV positivity. The change in international unit per milliliter will be compared among the three intervention groups (i.e., placebo or control cohort, those assigned to 20mg ezetimibe per day, and 40mg ezetimibe per day). Change is calculated based on 8 weeks minus baseline (0 weeks).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

0 weeks, 8 weeks

Results posted on

2022-06-06

Participant Flow

Patients are enrolled, but then are not randomized until they pick up clinical and study medication with the investigational pharmacist at a subsequent visit. As such, one can be enrolled but never randomized if they patient does not return for the medication.

Participant milestones

Participant milestones
Measure	Placebo placebo Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks	20mg/Day Ezetimibe 20mg/day ezetimibe 20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1 Participants placebo Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks	20mg/Day Ezetimibe n=1 Participants 20mg/day ezetimibe 20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks.	40mg/Day Ezetimibe 40mg/day ezetimibe 40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized non-hispanic White	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized non-hispanic Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
HCV RNA	4030000 International Units per mL n=5 Participants	5860000 International Units per mL n=7 Participants	—	4945000 International Units per mL n=4 Participants
alanine transaminase (ALT)	109 Units/Liter n=5 Participants	105 Units/Liter n=7 Participants	—	107 Units/Liter n=4 Participants

PRIMARY outcome

Timeframe: 0 weeks, 8 weeks

Population: Participants who were enrolled, were not randomized until they received their study medication. No one was randomized to the 40mg/day arm

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants placebo Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks	20mg/Day Ezetimibe n=1 Participants 20mg/day ezetimibe 20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks.	40mg/Day Ezetimibe 40mg/day ezetimibe 40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks.
Change in Viral Load	-4030000 international units per milliliter Interval -4030000.0 to -4030000.0	-5860000 international units per milliliter Interval -5860000.0 to -5860000.0	—

PRIMARY outcome

Timeframe: 3 days through 4 weeks

Population: Participants who were enrolled, were not randomized until they received their study medication. No one was randomized to the 40mg/day arm

HCV declines in a biphasic manner under HCV treatment. Here we are measuring the slope (i.e., rate) at which HCV is declining during the second slower phase of viral decline.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants placebo Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks	20mg/Day Ezetimibe n=1 Participants 20mg/day ezetimibe 20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks.	40mg/Day Ezetimibe 40mg/day ezetimibe 40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks.
Second Phase Slope	.90 log(copies/mL)/day Interval 0.9 to 0.9	.98 log(copies/mL)/day Interval 0.98 to 0.98	—

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants who were enrolled, were not randomized until they received their study medication. No one was randomized to the 40mg/day arm

Participants will have their ALT levels measured in units per liter (U/L) at baseline and 8 weeks. ALT ranges from 0 to infinity with higher levels of ALT indicating hepatocyte death. The change in ALT levels will be compared among the three intervention groups (i.e., placebo or control cohort, those assigned to 20mg ezetimibe per day, and 40mg ezetimibe per day).

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants placebo Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks	20mg/Day Ezetimibe n=1 Participants 20mg/day ezetimibe 20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks.	40mg/Day Ezetimibe 40mg/day ezetimibe 40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks.
Change in Alanine Aminotransferase (ALT)	-75 units per Liter Interval -75.0 to -75.0	-73 units per Liter Interval -73.0 to -73.0	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

20mg/Day Ezetimibe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

40mg/Day Ezetimibe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan L. Uprichard

Edward Hines Jr. Veterans Administration Hospital

Phone: (336) 402-1086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place