Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

Bausch Health

Status and phase: Terminated; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: Rifaximin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01846663

RFHE4043

Details and patient eligibility

About

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant, non-breast feeding female ≥ 18 years old
• In remission from demonstrated overt HE
• Had ≥1 episode of overt HE associated with liver disease within the last 6 months
• MELD score of ≥ 19
• Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial

Exclusion criteria

• HIV
• History of tuberculosis infection
• Chronic respiratory insufficiency
• Current infection and receiving antibiotics
• Renal insufficiency requiring dialysis
• Active spontaneous bacterial peritonitis infection
• Intestinal obstruction or has inflammatory bowel disease
• Active malignancy within the last 5 years
• Current GI bleeding or has had a GI hemorrhage within past 3 months
• Anemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

Rifaximin

Experimental group

Description:

Rifaximin, oral, 550 mg BID, 6 months of treatment

Treatment:

Drug: Rifaximin

Placebo

Placebo Comparator group

Description:

Placebo, oral, 0 mg BID, 6 months of treatment

Treatment:

Drug: Placebo