Phase 2
N=71
Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
Overt Hepatic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT03515044 ↗Enrolled (actual)
71
Serious AEs
34.7%
Results posted
Apr 2023
Primary outcome: Primary: Time to Overt Hepatic Encephalopathy (OHE) Resolution Determined Using the Hepatic Encephalopathy Grading Instrument (HEGI), Defined as HEGI Score < 2 — 36.1; 21.1; 45.9; 17.9 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 40 mg Rifaximin SSD once daily (Drug); 40 mg Rifaximin SSD twice daily (Drug); 80 mg Rifaximin SSD once daily (Drug); 80 mg Rifaximin SSD twice daily (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Overt Hepatic Encephalopathy (OHE) Resolution Determined Using the Hepatic Encephalopathy Grading Instrument (HEGI), Defined as HEGI Score < 2 |
36.1; 21.1; 45.9; 17.9; 62.7 | — |
| SECONDARY Time to Improvement in Hepatic Encephalopathy Grading Instrument (HEGI) Score, Defined as at Least One Grade Decrease (Improvement) |
2.5; 2.0; 2.0; 2.0; 3.0 | — |
| SECONDARY Time to Hospital Discharge |
3.0; 3.0; 3.0; 4.0; 4.5 | — |
Summary
Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).
Eligibility Criteria
Inclusion Criteria
- Male or female age 18 to 75 years of age (inclusive) at the time of screening.
- Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study.
Note: Female subjects who have been surgically sterilized (e.g., hysterectomy or bilateral tubal ligation) or who are postmenopausal (defined as total cessation of menses for > 1 year) will not be considered "female subjects of childbearing potential".
- Subject is hospitalized with liver cirrhosis and/or OHE and has a confirmed diagnosis of OHE at Baseline.
- Subject has a Grade 2 or Grade 3 HE episode according to the HE Grading Instrument (HEGI) following 8 to 12 hours of intravenous (IV) hydration and lactulose treatment.
Exclusion Criteria
- Subject has an uncontrolled major psychiatric disorder including major depression or psychoses as determined by the investigator.
- Subject has been diagnosed with an infection for which they are currently taking oral or parenteral antibiotics, which cannot be discontinued at time of enrollment. Note: Subjects currently taking Rifaximin are not excluded
- Subject shows presence of intestinal obstruction or has inflammatory bowel disease.
- Subject has uncontrolled Type 1 or Type 2 diabetes. Note: Subjects with controlled diabetes may be enrolled if they are on stable doses of oral hypoglycemic drugs for at least 3 months prior to screening, and demonstrate clinically acceptable blood glucose control at Baseline, as determined by the investigator.
- Subject has an active malignancy (exceptions: non-melanoma skin cancers).
Data sourced from ClinicalTrials.gov (NCT03515044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.