Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03995212
Status:
TERMINATED
Last Update Posted:
2023-07-03
First Post:
2019-06-19
Brief Title:
Study to Evaluate the Safety and Efficacy of Oral CR845 Difelikefalin in Patients With Primary Biliary Cholangitis PBC and Moderate-to-Severe Pruritus
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Patients With Primary Biliary Cholangitis PBC and Moderate-to-Severe Pruritus
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment due primarily to Covid-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled study to evaluate the safety and efficacy of twice-daily BID oral CR845 10 mg in patients with PBC with moderate-to-severe pruritus The study includes a 16-week Treatment Period
Detailed Description:
This study will consist of a Screening Visit a 7-day Run-in Period a 16-week Treatment Period and a Follow-up Visit approximately 7-10 days after the last dose of study drug Informed consent will be obtained prior to performing any study-specific procedures
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 11 ratio to receive either placebo or CR845 tablets at a dose of 10 mg orally BID for 16 weeks
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 11 ratio to receive either placebo or CR845 tablets at a dose of 10 mg orally BID for 16 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None