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Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C-3131)

Primary Purpose

Hepatic Encephalopathy

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rifaximin SSD
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of advanced liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (prophylactic variceal banding allowed if no history of previous variceal bleeding).
  • Conn (West Haven Criteria) score of < 2.
  • Mini-Mental State Examination (MMSE) score > 24 at screening and baseline.
  • ≥ 18 and ≤ 85 years of age.

Key Exclusion Criteria:

  • Active COVID-19, history of SBP, EVP or AKI-HRS
  • History of OHE episode (Conn score ≥ 2)
  • Use, among others, non-study rifaximin, lactulose/lactitol (with exception of prior occasional, intermittent use of lactulose for non-OHE indications), benzodiazepine, and chronic antibiotics.

Sites / Locations

  • Bausch Site 182Recruiting
  • Bausch Site 129Recruiting
  • Bausch Site 103Recruiting
  • Bausch Site 180
  • Bausch Site 153
  • Bausch Site 150Recruiting
  • Bausch Site 164Recruiting
  • Bausch Site 196
  • Bausch Site 174Recruiting
  • Bausch Site 163
  • Bausch Site 141Recruiting
  • Bausch Site 140Recruiting
  • Bausch Site 189
  • Bausch Site 119
  • Bausch Site 102Recruiting
  • Bausch Site 179
  • Bausch Site 115
  • Bausch Site 177Recruiting
  • Bausch Site 101Recruiting
  • Bausch Site 171
  • Bausch Site 183Recruiting
  • Bausch Site 143Recruiting
  • Bausch Site 151Recruiting
  • Bausch Site 121
  • Bausch Site 156
  • Bausch Site 197Recruiting
  • Bausch Site 173Recruiting
  • Bausch Site 139Recruiting
  • Bausch Site 138Recruiting
  • Bausch Site 157Recruiting
  • Bausch Site 166Recruiting
  • Bausch Site 186Recruiting
  • Bausch Site 147Recruiting
  • Bausch Site 188
  • Bausch Site 194
  • Bausch Site 120Recruiting
  • Bausch Site 152Recruiting
  • Bausch Site 135Recruiting
  • Bausch Site 128Recruiting
  • Bausch Site 124
  • Bausch Site 134Recruiting
  • Bausch Site 118Recruiting
  • Bausch Site 117Recruiting
  • Bausch Site 168Recruiting
  • Bausch Site 132
  • Bausch Site 161
  • Bausch Site 146
  • Bausch Site 136
  • Bausch Site 137Recruiting
  • Bausch Site 149Recruiting
  • Bausch Site 178Recruiting
  • Bausch Site 165
  • Bausch Site 191
  • Bausch Site 131
  • Bausch Site 125
  • Bausch Site 109
  • Bausch Site 116Recruiting
  • Bausch Site 192
  • Bausch Site 160
  • Bausch Site 114
  • Bausch Site 154
  • Bausch Site 167Recruiting
  • Bausch Site 185Recruiting
  • Bausch Site 110Recruiting
  • Bausch Site 104
  • Bausch Site 184
  • Bausch Site 145Recruiting
  • Bausch Site 181
  • Bausch Site 193Recruiting
  • Bausch Site 190
  • Bausch Site 144
  • Bausch Site 107
  • Bausch Site 133
  • Bausch Site 122
  • Bausch Site 123Recruiting
  • Bausch Site 172
  • Bausch Site 170Recruiting
  • Bausch Site 130Recruiting
  • Bausch Site 158Recruiting
  • Bausch Site 159Recruiting
  • Bausch Site 195Recruiting
  • Bausch Site 127
  • Bausch Site 112Recruiting
  • Bausch Site 175
  • Bausch Site 111Recruiting
  • Bausch Site 113Recruiting
  • Bausch Site 155Recruiting
  • Bausch Site 162Recruiting
  • Bausch Site 105
  • Bausch Site 300
  • Bausch Site 306
  • Bausch Site 304
  • Bausch Site 302
  • Bausch Site 305
  • Bausch Site 303
  • Bausch Site 307
  • Bausch Site 202
  • Bausch Site 203
  • Bausch Site 201Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifaximin SSD-40mg IR

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to first event of overt hepatic encephalopathy requiring hospitalization

Secondary Outcome Measures

Time to first Conn score ≥ 2
Time to all-cause hospitalization
Time to first event of OHE that requires hospitalization, or all-cause death

Full Information

First Posted
September 28, 2021
Last Updated
April 7, 2023
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05071716
Brief Title
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Acronym
RED-C-3131
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
466 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin SSD-40mg IR
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin SSD
Intervention Description
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Twice Daily
Primary Outcome Measure Information:
Title
Time to first event of overt hepatic encephalopathy requiring hospitalization
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Time to first Conn score ≥ 2
Time Frame
72 weeks
Title
Time to all-cause hospitalization
Time Frame
72 weeks
Title
Time to first event of OHE that requires hospitalization, or all-cause death
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past). Conn (West Haven Criteria) score of < 2. Mini-Mental State Examination (MMSE) score > 24 at screening. ≥ 18 and ≤ 85 years of age. Key Exclusion Criteria: Active COVID-19 that is unresolved History of SBP History of EVB or AKI-HRS within 6 months History of OHE episode (Conn score ≥ 2)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nupur Murali
Phone
(609) 218-9883
Email
nupur.murali@bauschhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mader
Organizational Affiliation
Bausch Health
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 182
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 129
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 103
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 180
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 153
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 150
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
77205
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 164
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 196
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 174
City
Escondido
State/Province
California
ZIP/Postal Code
920125
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 163
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 141
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 140
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 189
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 119
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 102
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 179
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 115
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 177
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 101
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 171
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 183
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 143
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 151
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 121
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 156
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 197
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 173
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 139
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 138
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 157
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 166
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 186
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 147
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 188
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 194
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 120
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 152
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 135
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 128
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 124
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 134
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 118
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 117
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 168
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 132
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 161
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 146
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 136
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 137
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 149
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 178
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 165
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 191
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 131
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 125
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 109
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 116
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 192
City
Durham
State/Province
North Carolina
ZIP/Postal Code
22710
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 160
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 114
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 154
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 167
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 185
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 110
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 104
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 184
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 145
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 181
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 193
City
Austin
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 190
City
Baytown
State/Province
Texas
ZIP/Postal Code
77523
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 144
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 107
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 133
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 122
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 123
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 172
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 170
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 130
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 158
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 159
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 195
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 127
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 112
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 175
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 111
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 113
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 155
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 162
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 105
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 300
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 306
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 304
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 302
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 305
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 303
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 307
City
Concord
ZIP/Postal Code
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 202
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2R3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 203
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 0B1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site 201
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

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