Hepatic Encephalopathy Clinical Trial
— RED-C-3132Official 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
| Verified date | May 2024 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study RNLC3132 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.
| Status | Active, not recruiting |
| Enrollment | 466 |
| Est. completion date | January 2026 |
| Est. primary completion date | January 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Bausch Site 709 | Camperdown | New South Wales |
| Australia | Bausch Site 710 | Westmead | New South Wales |
| Belgium | Bausch Site 972 | Antwerpen | |
| Belgium | Bausch Site 978 | Genk | |
| Belgium | Bausch Site 973 | Gent | |
| Belgium | Bausch Site 976 | Kortrijk | |
| Belgium | Bausch Site 974 | Liege | |
| Belgium | Bausch Site 975 | Mechelen | |
| Bulgaria | Bausch Site 982 | Ruse | |
| Bulgaria | Bausch Site 969 | Sliven | |
| Bulgaria | Bausch Site 967 | Sofia | |
| Bulgaria | Bausch Site 968 | Sofia | |
| Bulgaria | Bausch Site 984 | Sofia | |
| Bulgaria | Bausch Site 966 | Stara Zagora | |
| Canada | Bausch Site Barrie GI Associates | Barrie | Ontario |
| Canada | Bausch Site Brampton Civic Hospital | Brampton | Ontario |
| Canada | Bausch Site Heritage Medical Research Clinic | Calgary | Alberta |
| Canada | Bausch Site University of Alberta Hospital | Edmonton | Alberta |
| Canada | Bausch Site McMaster University Medical Centre - Hamilton Health Services | Hamilton | Ontario |
| Canada | Bausch Site Clinique Medicale L'Actuel | Montreal | Quebec |
| Canada | Bausch Site: CHUM Centre de Recherche | Montreal | Quebec |
| Canada | Bausch Site 605 | Quebec | |
| Canada | Bausch Site Albany Medical Clinic | Toronto | Ontario |
| Canada | Bausch Site Toronto General Hospital | Toronto | Ontario |
| Canada | Bausch Site G.I.R.I. GI Research Institute | Vancouver | British Columbia |
| Canada | Bausch Site: Pharmaceutical Integrated Research Corporation | Waterloo | Ontario |
| France | Bausch Site 804 | Angers | |
| France | Bausch Site 818 | Belfort | |
| France | Bausch Site 810 | Besançon | |
| France | Bausch Site 802 | Clermont-Ferrand | |
| France | Bausch Site 808 | Limoges | |
| France | Bausch Site 805 | Lyon | |
| France | Bausch Site 807 | Nice | |
| France | Bausch Site 801 | Paris | |
| France | Bausch Site 817 | Paris | |
| France | Bausch Site 809 | Pessac | |
| France | Bausch Site 815 | Rennes | |
| France | Bausch Site 803 | Toulouse | |
| France | Bausch Site 813 | Vandœuvre-lès-Nancy | |
| France | Bausch Site 811 | Villejuif | |
| Germany | Bausch Site 737 | Berlin | |
| Hungary | Bausch Site 859 | Budapest | |
| Hungary | Bausch Site 856 | Debrecen | |
| India | Bausch Site 352 | Belgaum | |
| India | Bausch Site 350 | Mangaluru | |
| India | Bausch Site 356 | Nagpur | |
| India | Bausch Site 354 | Nashik | |
| India | Bausch Site 361 | Secunderabad | |
| India | Bausch Site 351 | Surat | |
| Italy | Bausch Site 881 | Milano | |
| Italy | Bausch Site 883 | Napoli | |
| Italy | Bausch Site 884 | Novara | |
| Italy | Bausch Site 882 | Palermo | |
| Italy | Bausch Site 879 | Rozzano | |
| Korea, Republic of | Bausch Site 751 | Busan | |
| Korea, Republic of | Bausch Site 759 | Busan | |
| Korea, Republic of | Bausch Site 764 | Daegu | |
| Korea, Republic of | Bausch Site 769 | Daegu | |
| Korea, Republic of | Bausch Site 763 | Daejeon | |
| Korea, Republic of | Bausch Site 768 | Gangwon-do | |
| Korea, Republic of | Bausch Site 758 | Goyang-si | |
| Korea, Republic of | Bausch Site 765 | Gyeonggi-do | |
| Korea, Republic of | Bausch Site 754 | Gyeongsang | |
| Korea, Republic of | Bausch Site 770 | Seongnam-si | |
| Korea, Republic of | Bausch Site 752 | Seoul | |
| Korea, Republic of | Bausch Site 753 | Seoul | |
| Korea, Republic of | Bausch Site 755 | Seoul | |
| Korea, Republic of | Bausch Site 757 | Seoul | |
| Korea, Republic of | Bausch Site 760 | Seoul | |
| Korea, Republic of | Bausch Site 762 | Seoul | |
| Korea, Republic of | Bausch Site 766 | Seoul | |
| Korea, Republic of | Bausch Site 767 | Seoul | |
| Korea, Republic of | Bausch Site 761 | Yongin-si | |
| Mongolia | Bausch Site 970 | Ulaan Baatar | |
| New Zealand | Bausch Site 779 | Christchurch | |
| New Zealand | Bausch Site 776 | Grafton | |
| New Zealand | Bausch Site 778 | Hamilton | |
| Poland | Bausch Site 902 | Bydgoszcz | |
| Poland | Bausch Site 904 | Katowice | |
| Poland | Bausch Site 909 | Kraków | |
| Poland | Bausch Site 901 | Myslowice | |
| Poland | Bausch Site 903 | Staszów | |
| Poland | Bausch Site 906 | Wroclaw | |
| Poland | Bausch Site 908 | Wroclaw | |
| Puerto Rico | Bausch Site 440 | Guaynabo | |
| Puerto Rico | Bausch Site 589 | San Juan | |
| Spain | Bausch Site 931 | Barcelona | |
| Spain | Bausch Site 937 | Madrid | |
| Spain | Bausch Site 928 | Málaga | |
| Spain | Bausch Site 936 | Pontevedra | |
| Spain | Bausch Site 933 | Valencia | |
| Spain | Bausch Site 935 | Valencia | |
| Spain | Bausch Site 927 | Zaragoza | |
| United Kingdom | Bausch Site 941 | Dundee | |
| United Kingdom | Bausch Site 947 | Hull | |
| United Kingdom | Bausch Site 946 | Liverpool | |
| United Kingdom | Bausch Site 945 | Nottingham | |
| United Kingdom | Bausch Site 942 | Plymouth | |
| United States | Bausch Site 581 | Allentown | Pennsylvania |
| United States | Bausch Site 427 | Asheville | North Carolina |
| United States | Bausch Site 550 | Bakersfield | California |
| United States | Bausch Site 401 | Bronx | New York |
| United States | Bausch Site 402 | Burlington | Vermont |
| United States | Bausch Site 445 | Chandler | Arizona |
| United States | Bausch Site 423 | Chattanooga | Tennessee |
| United States | Bausch Site 434 | Chattanooga | Tennessee |
| United States | Bausch Site 575 | Colorado Springs | Colorado |
| United States | Bausch Site 599 | Columbia | South Carolina |
| United States | Bausch Site 415 | Coronado | California |
| United States | Bausch Site 585 | Covina | California |
| United States | Bausch Site 585 | Covina | California |
| United States | Bausch Site 406 | Dallas | Texas |
| United States | Bausch Site 410 | Dayton | Ohio |
| United States | Bausch Site 519 | Denison | Texas |
| United States | Bausch Site 425 | Doral | Florida |
| United States | Bausch Site 436 | East Syracuse | New York |
| United States | Bausch Site 598 | Florham Park | New Jersey |
| United States | Bausch Site 463 | Flowood | Mississippi |
| United States | Bausch Site 597 | Freehold | New Jersey |
| United States | Bausch Site 592 | Fresno | California |
| United States | Bausch Site 583 | Greenbelt | Maryland |
| United States | Bausch Site 475 | Gurnee | Illinois |
| United States | Bausch Site 400 | Harrisburg | Pennsylvania |
| United States | Bausch Site 579 | Hermitage | Tennessee |
| United States | Bausch Site 418 | Hialeah | Florida |
| United States | Bausch Site 449 | Hialeah | Florida |
| United States | Bausch Site 558 | Hialeah | Florida |
| United States | Bausch Site 468 | Hollywood | Florida |
| United States | Bausch Site 591 | Homewood | Alabama |
| United States | Bausch Site 437 | Houston | Texas |
| United States | Bausch Site 447 | Humble | Texas |
| United States | Bausch Site 460 | Jefferson City | Missouri |
| United States | Bausch Site 457 | Lafayette | Louisiana |
| United States | Bausch Site 582 | Lancaster | California |
| United States | Bausch Site 580 | Liberty Township | Ohio |
| United States | Bausch Site 590 | Long Beach | California |
| United States | Bausch Site 414 | Los Angeles | California |
| United States | Bausch Site 577 | Macon | Georgia |
| United States | Bausch Site 531 | Marrero | Louisiana |
| United States | Bausch Site 488 | Metairie | Louisiana |
| United States | Bausch Site 428 | Miami | Florida |
| United States | Bausch Site 435 | Miami | Florida |
| United States | Bausch Site 456 | Miami | Florida |
| United States | Bausch Site 458 | Miami | Florida |
| United States | Bausch Site 470 | Miami | Florida |
| United States | Bausch Site 479 | Miami | Florida |
| United States | Bausch Site 486 | Miami | Florida |
| United States | Bausch Site 495 | Miami | Florida |
| United States | Bausch Site 543 | Miami | Florida |
| United States | Bausch Site 552 | Miami | Florida |
| United States | Bausch Site 594 | Miami | Florida |
| United States | Bausch Site 452 | Miami Lakes | Florida |
| United States | Bausch Site 494 | Monroe | North Carolina |
| United States | Bausch Site 413 | New Orleans | Louisiana |
| United States | Bausch Site 559 | Norfolk | Virginia |
| United States | Bausch Site 431/443 | Ocala | Florida |
| United States | Bausch Site 450 | Ocala | Florida |
| United States | Bausch Site 446 | Ocoee | Florida |
| United States | Bausch Site 405 | Orange | California |
| United States | Bausch Site 421 | Orange City | Florida |
| United States | Bausch Site 596 | Orlando | Florida |
| United States | Bausch Site 537 | Palmetto Bay | Florida |
| United States | Bausch Site 576 | Philadelphia | Pennsylvania |
| United States | Bausch Site 407 | Port Orange | Florida |
| United States | Bausch Site 484 | Providence | Rhode Island |
| United States | Bausch Site 424 | Richmond | Virginia |
| United States | Bausch Site 490 | Richmond | Virginia |
| United States | Bausch Site 595 | Richmond | Virginia |
| United States | Bausch Site 404 | Roanoke | Virginia |
| United States | Bausch Site 448 | San Marcos | Texas |
| United States | Bausch Site 442 | Shreveport | Louisiana |
| United States | Bausch Site 422 | Smithfield | North Carolina |
| United States | Bausch Site 588 | South Bend | Indiana |
| United States | Bausch Site 411 | Sparta | New Jersey |
| United States | Bausch Site 403 | Springboro | Ohio |
| United States | Bausch Site 480 | Summerville | South Carolina |
| United States | Bausch Site 453 | Sun City | Arizona |
| United States | Bausch Site 455 | Toms River | New Jersey |
| United States | Bausch Site 524 | Topeka | Kansas |
| United States | Bausch Site 587 | Tucson | Arizona |
| United States | Bausch Site 600 | Union City | Tennessee |
| United States | Bausch Site 482 | Valencia | California |
| United States | Bausch Site 409 | Waco | Texas |
| United States | Bausch Site 454 | Wellington | Florida |
| United States | Bausch Site 466 | West Des Moines | Iowa |
| United States | Bausch Site 472 | Westlake | Ohio |
| United States | Bausch Site 416 | Wichita Falls | Texas |
| United States | Bausch Site 429 | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Australia, Belgium, Bulgaria, Canada, France, Germany, Hungary, India, Italy, Korea, Republic of, Mongolia, New Zealand, Poland, Puerto Rico, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first event of overt hepatic encephalopathy requiring hospitalization | 72 weeks | ||
| Secondary | Time to first Conn score = 2 | 72 weeks | ||
| Secondary | Time to all-cause hospitalization | 72 weeks | ||
| Secondary | Time to first event of OHE that requires hospitalization, or all-cause death | 72 weeks |
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