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Unknown

CNP-104 for Primary Biliary Cholangitis

Phase 1 & 2
Waitlist Available
Led By Christopher Bowlus, MD
Research Sponsored by COUR Pharmaceutical Development Company, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with a PBC diagnosis as demonstrated by specific diagnostic factors
Female subjects who agree not to donate ova
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through visit 7, an average of 90 days and visit 16, an average of 720 days
Awards & highlights

Study Summary

This trial is to study a new drug's safety, how well it works, and if it has long-term effects.

Who is the study for?
Adults aged 18-75 with Primary Biliary Cholangitis (PBC) unresponsive to standard treatments, having specific diagnostic factors like high alkaline phosphatase or positive PBC-specific antibodies. Participants must not be pregnant, agree to use effective contraception, and have liver function within certain limits. Excludes those with other liver diseases, history of organ transplant or severe cardiovascular events.Check my eligibility
What is being tested?
The trial is testing CNP-104's safety and effectiveness in treating PBC compared to a placebo over a period of about two years. It involves multiple doses of the drug and monitors how well it works and its long-term effects on patients who haven't responded well to existing treatments.See study design
What are the potential side effects?
While the side effects for CNP-104 are not detailed here, common risks may include allergic reactions to components of the drug, potential impact on liver function given the patient population, and general medication-related issues such as nausea or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with primary biliary cholangitis.
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I agree not to donate eggs during the trial.
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I agree not to donate sperm during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through visit 7, an average of 90 days and visit 16, an average of 720 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through visit 7, an average of 90 days and visit 16, an average of 720 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Laboratory safety assessments (hematology, serum chemistry, coagulation panel, urinalysis).
Serum Cytokines (TNF-α, IL-4, IL-6, IL-10, IL-1β, MCP-1, MIP-1α, IFN-γ)
+1 more
Secondary outcome measures
To assess the change from baseline in ALP levels, for safety only
To assess the change from baseline in AMA
To assess the change from baseline in Weekly Mean Itch Score
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 8 mg/Kg CNP-104Experimental Treatment1 Intervention
200 mL intravenous infusion on Day 1 and Day 8: 8 mg/Kg CNP-104
Group II: 4 mg/Kg CNP-104Experimental Treatment1 Intervention
200 mL intravenous infusion on Day 1 and Day 8: 4 mg/Kg CNP-104
Group III: PlaceboPlacebo Group1 Intervention
200 mL intravenous infusion on Day 1 and Day 8: Placebo

Find a Location

Who is running the clinical trial?

COUR Pharmaceutical Development Company, Inc.Lead Sponsor
4 Previous Clinical Trials
101 Total Patients Enrolled
Christopher Bowlus, MDPrincipal InvestigatorUC Davis
1 Previous Clinical Trials

Media Library

CNP-104 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05104853 — Phase 1 & 2
Primary Biliary Cirrhosis Research Study Groups: 4 mg/Kg CNP-104, 8 mg/Kg CNP-104, Placebo
Primary Biliary Cirrhosis Clinical Trial 2023: CNP-104 Highlights & Side Effects. Trial Name: NCT05104853 — Phase 1 & 2
CNP-104 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05104853 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the core goals of this investigation?

"This trial has two main objectives, which will be evaluated at Visit 6 after an average of 60 Days. The primary goal is to measure the Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). As for secondary targets, researchers are looking into Change from baseline in enhanced liver fibrosis (ELF) score between placebo and CNP-104 at Day 90., Change from baseline in modified PBC-40 score between placebo and CNP-104 at Day 90., as well as Serum Cytokines (TNF-α, IL-4, IL-6, IL-10, IL-"

Answered by AI

What is the uppermost limit of participants involved in this trial?

"Affirmative. Clinicaltrials.gov's records state that the medical study is actively seeking out volunteers, with an initial posting date of January 25th 2022 and a most recent update from November 7th 2022. The trial requires 40 participants to be recruited from 20 sites."

Answered by AI

How many locations are actively participating in this experiment?

"Currently, 20 distinct clinical trial sites are available for this study. Notably, Weston, New Haven and Winston-Salem all have research centres involved in the project with other locations scattered across the country. To minimize travel requirements if you decide to join, please select a site close by your location."

Answered by AI

Does this clinical trial accept participants above the age of thirty?

"This trial only permits adults between the ages of 18 and 75 to participate. For those younger than 18 or older than 65, there are 4 studies and 46 respectively available for them."

Answered by AI

Am I eligible to partake in this experiment?

"This clinical trial is enrolling 40 participants aged 18-75 that have been diagnosed with cholangitis. Eligibility requirements for enrolment include: providing written consent approved by the Institutional Review Board, being of non-pregnant gender, having alkaline phosphatase levels above 1.5x upper limit of normal (ULN) for at least 6 months, possessing positive anti-mitochondrial antibodies titers or other PBC specific antibodies if AMA titer is low (<1:40), liver biopsy findings consistent with primary biliary cirrhosis (PBC), unresponsiveness to ursodeoxy"

Answered by AI

Are there still opportunities to participate in this experiment?

"As denoted on clinicaltrials.gov, this medical trial is in need of participants and was first posted on January 25th 2022 with the latest update occurring November 7th 2022."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Henry Ford Health System

Why did patients apply to this trial?

I’ve tried numerous insomnia meds to no avail.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
2022. "Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05104853.
All > Liver Cirrhosis > Primary Biliary Cirrhosis
~18 spots leftby Dec 2025
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