Trial Outcomes & Findings for Rifaximin in Fatty Liver Disease (NCT NCT01355575)

Results Overview

Alanine aminotransferase (ALT) after 6-weeks of Rifaximin from baseline (end of treatment) and 12 weeks (6 weeks after end of treatment). ALT values reported are the values from 6-weeks Rifaximin treatment compared to baseline, and ALT values from 12 weeks (after 6 weeks of SoC) compared to baseline.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Baseline, 6 weeks (end of treatment) and 12 weeks (6 weeks after end of treatment)

Results posted on

2020-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Rifaximin for 6-weeks Then Standard Care Rifaximin for 6 weeks in addition to standard care, followed by 6 weeks observation period during which patients receive standard care. Rifaximin: Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Rifaximin for 6-weeks Then Standard Care Rifaximin for 6 weeks in addition to standard care, followed by 6 weeks observation period during which patients receive standard care. Rifaximin: Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Rifaximin in Fatty Liver Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Combined n=15 Participants All patients in one group
Age, Continuous	46 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks (end of treatment) and 12 weeks (6 weeks after end of treatment)

Alanine aminotransferase (ALT) after 6-weeks of Rifaximin from baseline (end of treatment) and 12 weeks (6 weeks after end of treatment). ALT values reported are the values from 6-weeks Rifaximin treatment compared to baseline, and ALT values from 12 weeks (after 6 weeks of SoC) compared to baseline.

Outcome measures

Outcome measures
Measure	Rifaximin for 6-weeks n=15 Participants Phase 1 Rifaximin: Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.	Standard of Care for 6-weeks n=15 Participants Phase 2 The 6-weeks Rifaximin treatment was followed by an observation period for 6-weeks during which patients received standard of care. All patients who had received Rifaximin for 6-weeks then received standard of care for the 6-week period.
Serum Alanine Aminotransferase (ALT) Levels	63 iu/L Interval 41.0 to 218.0	83 iu/L Interval 30.0 to 217.0

SECONDARY outcome

Timeframe: Baseline and 6 weeks (end of treatment)

Population: Data not collected during standard of care.

Hepatic and systemic insulin resistance assessed using the hyperinsulinaemic euglycaemic clamp method. Measured in % Suppression of Endogenous Glucose Production (SEGP). Values reported are the value from baseline and value from 6 weeks Rifaximin treatment.

Outcome measures

Outcome measures
Measure	Rifaximin for 6-weeks n=14 Participants Phase 1 Rifaximin: Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.	Standard of Care for 6-weeks n=14 Participants Phase 2 The 6-weeks Rifaximin treatment was followed by an observation period for 6-weeks during which patients received standard of care. All patients who had received Rifaximin for 6-weeks then received standard of care for the 6-week period.
Insulin Resistance	35.2 % SEGP Interval 15.3 to 51.7	30 % SEGP Interval 10.8 to 50.5

SECONDARY outcome

Timeframe: Baseline and 6 weeks (end of treatment)

Population: Data not collected during standard of care.

In vivo proton magnetic resonance spectroscopy (1H MRS) to derive a T2-corrected triglyceride to water ratio (hepatic lipid content- intra-hepatocellular lipid (IHCL)). The values reported are the values from baseline and the values from 6 weeks Rifaximin treatment.

Outcome measures

Outcome measures
Measure	Rifaximin for 6-weeks n=14 Participants Phase 1 Rifaximin: Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.	Standard of Care for 6-weeks n=14 Participants Phase 2 The 6-weeks Rifaximin treatment was followed by an observation period for 6-weeks during which patients received standard of care. All patients who had received Rifaximin for 6-weeks then received standard of care for the 6-week period.
Hepatic Triglyceride Content	21.6 % hepatic lipid content Interval 2.2 to 46.2	24.8 % hepatic lipid content Interval 1.7 to 59.3

Adverse Events

Rifaximin for 6-weeks

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care for 6-weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rifaximin for 6-weeks n=15 participants at risk Participants received rifaximin tablet, oral administration, 400mg twice daily for 6-weeks.	Standard of Care for 6-weeks n=15 participants at risk The 6-weeks Rifaximin treatment was followed by an observation period for 6-weeks during which patients received standard of care. All patients who had received Rifaximin for 6-weeks then received standard of care for the 6-week period.
Gastrointestinal disorders Loose stool	6.7% 1/15 • Number of events 1 • 12 weeks	0.00% 0/15 • 12 weeks

Additional Information

Dr Jeremy Cobbold

Imperial College London

Phone: +44 1865228756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place