Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
NCT ID: NCT03995212
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
14 participants
INTERVENTIONAL
2019-06-25
2022-06-29
Brief Summary
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Detailed Description
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The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility.
Day 1 of the Treatment Period will be defined as the day of the administration of the first dose of study drug. If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1 ratio to receive either placebo or CR845 tablets at a dose of 1.0 mg orally BID for 16 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CR845 1.0 mg
Oral CR845 1.0 mg tablet administered twice daily
CR845 1.0 mg
Oral CR845 1.0 mg administered twice daily
Placebo
Oral placebo tablet administered twice daily
Placebo
Oral Placebo administered twice daily
Interventions
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CR845 1.0 mg
Oral CR845 1.0 mg administered twice daily
Placebo
Oral Placebo administered twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of PBC;
* If currently taking ursodeoxycholic acid (UDCA), should be on stable dose for \>12 weeks prior to screening and plan on continuing to take UDCA throughout the study;
* If previously taking UDCA, should have discontinued its use \>12 weeks prior to screening;
* Self-reports experiencing daily or near-daily pruritus during the month prior to screening;
* Prior to randomization has a mean baseline WI-NRS score indicative of moderate to severe pruritus.
Exclusion Criteria
* Presence of Child-Pugh Class C decompensated cirrhosis at screening;
* Itching secondary to biliary obstruction;
* History or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein thrombosis;
* Current placement on liver transplantation list with anticipated liver transplant during the course of the study or current Model for End-stage Liver Disease (MELD) score ≥15;
* Alanine aminotransferase or aspartate aminotransferase \>5 × upper limit of normal at screening, or within 2 months prior to screening;
* Anticipates receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) from the start of screening through the end of the Treatment Period;
* New or change of treatment with antihistamines and corticosteroids (oral, intravenous, or topical), opioids, gabapentin, pregabalin, cholestyramine, rifampicin or fibrates within 14 days prior to screening.
18 Years
80 Years
ALL
No
Sponsors
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Cara Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frédérique Menzaghi, PhD
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
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Cara Therapeutics Study Site
Coronado, California, United States
Cara Therapeutics Study Site
Rialto, California, United States
Cara Therapeutics Study Site
San Francisco, California, United States
Cara Therapeutics Study Site
Colorado Springs, Colorado, United States
Cara Therapeutics Study Site
Miami, Florida, United States
Cara Therapeutics Study Site
Plantation, Florida, United States
Cara Therapeutics Study Site
Indianapolis, Indiana, United States
Cara Therapeutics Study Site 2
Boston, Massachusetts, United States
Cara Therapeutics Study Site
Boston, Massachusetts, United States
Cara Therapeutics Study Site
New York, New York, United States
Cara Therapeutics Study Site
Nashville, Tennessee, United States
Cara Therapeutics Study Site
Arlington, Texas, United States
Cara Therapeutics Study Site
Newport News, Virginia, United States
Cara Therapeutics Study Site
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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CR845-210401
Identifier Type: -
Identifier Source: org_study_id
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