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Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) (OHE)

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ClinicalTrials.gov Identifier: NCT03515044
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Overt Hepatic Encephalopathy Drug: 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: lactulose Phase 2

Detailed Description:
The primary objective of this study is to assess the efficacy of rifaximin SSD plus lactulose versus placebo plus lactulose for the treatment of overt hepatic encephalopathy (OHE). The secondary objectives of this study are to assess the safety of rifaximin SSD in subjects with OHE and to assess the effects of treatment with rifaximin SSD on key secondary endpoints.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Blinding will be maintained in the QD SSD cohorts by administering placebo as the second daily dose.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 40 mg Rifaximin SSD once daily
40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose
Drug: 40 mg Rifaximin SSD once daily
SSD once daily (QD) and lactulose

Drug: lactulose
to be taken in the recommended adult size dosage.

Experimental: Cohort 2 40 mg Rifaximin SSD twice daily
40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose
Drug: 40 mg Rifaximin SSD twice daily
SSD twice daily (BID) and lactulose

Drug: lactulose
to be taken in the recommended adult size dosage.

Experimental: Cohort 3 80 mg Rifaximin SSD once daily
80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose
Drug: 80 mg Rifaximin SSD once daily
SSD once daily (QD) and lactulose

Drug: lactulose
to be taken in the recommended adult size dosage.

Experimental: Cohort 4 80 mg Rifaximin SSD twice daiy
Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose
Drug: 80 mg Rifaximin SSD twice daily
SSD twice daily (BID) and lactulose

Drug: lactulose
to be taken in the recommended adult size dosage.

Experimental: Cohort 5 Placebo twice daily
SSD placebo twice daily (BID) and lactulose
Drug: Placebo
Administered twice daily (BID) and lactulose

Drug: lactulose
to be taken in the recommended adult size dosage.




Primary Outcome Measures :
  1. Time to OHE resolution determined using the Hepatic Encephalopathy Grading Instrument (HEGI). [ Time Frame: 3 to 12 hours after administration ]
    Major diagnostic criteria include: (1) disorientation (time, place, and/or person), or (2) presence of both lethargy and asterixis, or (3) coma. Inter- and intra-rater HEGI reproducibility



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515044


Contacts
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Contact: Lindsey Mathew 9089270873 lindsey.mathew@bauschhealth.com

  Show 34 Study Locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Lindsey Mathew Valeant Pharmaceuticals

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03515044     History of Changes
Other Study ID Numbers: RNHE2041
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Lactulose
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents