Johnson City, TNNCT07387549Now EnrollingIRB Ready

Primary Sclerosing Cholangitis Clinical Trial in Johnson City, TN

Access cutting-edge primary sclerosing cholangitis treatment through this clinical trial at a research site in Johnson City. Study-provided care at no cost to qualified participants.

Sponsored by Ipsen

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Expert Care in Johnson City

Access primary sclerosing cholangitis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related primary sclerosing cholangitis treatment provided free

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Check if you qualify for this primary sclerosing cholangitis clinical trial in Johnson City, TN

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Why Participate?

  • No-Cost Study Care

  • Local to Johnson City

    Convenient for TN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Johnson City site if eligible
  4. 4Begin participation

About This Primary Sclerosing Cholangitis Study in Johnson City

The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death. In this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up. During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety. Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.

Sponsor: Ipsen

Who Can Participate

Inclusion Criteria

Adults participants aged 18 years or older
Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
Compensated liver disease at screening
Stable background therapy, where applicable prior to study entry
Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control
Ability to provide written informed consent and comply with study procedures.

Exclusion Criteria

\- History or presence of other concomitant chronic liver disease \- History of hepatic decompensation, including: i) History of liver transplantation, current MELD 3.0 score ≥12 due to hepatic impairment. ii) Evidence of complications of cirrhosis
Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score.
History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.
History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.
History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma
Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
Administration of the following medications are prohibited as specified below: i) 3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones. ii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).
Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to the SV. - Participants with previous exposure to elafibranor.
Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block.
Significant renal disease,
For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.
Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women
History of alcohol abuse, or other substance abuse within 1 year prior to SV.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study.
Mental instability or incompetence
Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.
Medical conditions that may diminish life expectancy to \<2 years.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Johnson City?

Yes, this clinical trial (NCT07387549) has an active research site in Johnson City, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Primary Sclerosing Cholangitis Treatment Options in Johnson City, TN

If you're searching for primary sclerosing cholangitis treatment options in Johnson City, TN, this clinical trial (NCT07387549) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Johnson City research site is actively enrolling participants for this clinical trial. You'll receive care from experienced primary sclerosing cholangitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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