The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Bausch Health

Status and phase: Completed; Phase 4

Conditions: Hepatic Encephalopathy; Cirrhosis

Treatments: Drug: Rifaximin; Drug: Lactulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01842581

RFHE4044

Details and patient eligibility

About

The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant, non-lactating females greater than or equal to (≥) 18 years old.
• In remission from demonstrated overt HE (Conn score 0 or 1).
• Have had one or more episodes of overt HE associated with cirrhosis within 6 months prior to screening visit (Day -7 to -1).
• Participant has a close family member or other personal contact who is familiar with the participant's HE and can provide continuing oversight to the participant and is willing to perform as caregiver for the participant during the conduct of the trial.

Exclusion criteria

• Participant has been diagnosed with human immunodeficiency virus (HIV) as determined by medical history.
• History of tuberculosis infection.
• Participant has been diagnosed with chronic respiratory insufficiency.
• Participant has been diagnosed with a current infection for which they are currently taking oral or parenteral antibiotics.
• Renal insufficiency requiring routine dialysis.
• Participant has an active spontaneous bacterial peritonitis(SBP) infection.
• Intestinal obstruction or inflammatory bowel disease.
• Participant has active malignancy within the last 5 years prior to screening visit, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
• Current gastrointestinal (GI) bleeding or has a history of a GI hemorrhage of sufficient severity to require hospitalization and a transfusion of ≥2 units of blood within 3 months prior to screening visit.
• Participant is anemic, as defined by a hemoglobin of less than (<) 8 grams/deciliter (g/dL).
• Scheduled to receive a liver transplant within 1 month of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Rifaximin 550 mg BID

Experimental group

Description:

Participants will receive rifaximin 550 milligrams (mg) tablet orally twice daily (BID) for 24 weeks.

Treatment:

Drug: Rifaximin

Rifaximin 550 mg BID + Lactulose

Experimental group

Description:

Participants will receive rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose will be self-titrated by the participant to produce 2 to 3 soft stools per day.

Treatment:

Drug: Rifaximin

Drug: Lactulose