Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis

July 25, 2023 updated by: CuromeBiosciences

A Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Therapeutic Exploratory Phase 2 Clinical Study to Evaluate the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis (PSC)

The objective of this study is to evaluate the improvement of bile duct strictures following the administration of HK-660S in patients with Primary Sclerosing Cholangitis(PSC). Percentage of subjects who show improvement of severity of PSC as assessed by Magnetic Resonance Cholangiopancreatography(MRCP) at Week 12 from baseline, with improvement defined as a decrease of -1 or more in the MRCP and change of alkaline phosphatase(ALP) level will be assessed at Week 12 from baseline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sclerosing cholangitis is a rare, chronic, cholestatic liver disease caused by inflammation and fibrosis of the intrahepatic/extrahepatic biliary tract. Its pathophysiology involves destruction and stricture of the bile duct due to diffuse inflammation and fibrosis of the bile duct. The selected subjects will be randomly assigned to either active or placebo groups and administered 100 mg of HK-660S or placebo (1 tablet) twice a day for 12 weeks. After Visit 2, subjects will visit the study center at Week 4 (Visit 3), Week 8 (Visit 4), Week 12 (Visit 5 / End of Treatment), and Week 16 (Visit 6 / Follow-up) to assess efficacy and safety.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 02080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female subjects aged ≥ 17 years
  • Subjects who have a diagnosis of PSC
  • Subjects who are able to understand the information provided directly or via his/her representative and give voluntary, written consent to participate in the study.

Exclusion Criteria:

  • Subjects with an average alcohol intake of more than 20g per day within 2 years prior to screening.
  • Subjects who have a diagnosis of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c ≥ 9%) prior to screening.
  • Subjects who have chronic liver diseases other than PSC
  • Subjects who have a diagnosis of primary biliary cirrhosis or secondary sclerosing cholangitis in MRCP or Endoscopic Retrograde Cholangiopancreatography(ERCP) prior to screening.
  • Subjects who have obstacles to MRCP implementation
  • Subjects who have a positive result of hepatitis B surface antigen (HBsAg test) and/or hepatitis C antibody (HCV-Ab test)
  • Subjects who have Alanine Aminotransferase(ALT) or Aspartate aminotransferase(AST) > 10 x upper limit of normal(ULN)
  • Subjects who have serum creatinine ≥ 2 mg/dl
  • Subjects who have weight changes of 5 kg or more within 6 months prior to screening
  • Subjects who are deemed unsuitable for participation in the study at Screening, at the discretion of the investigator, due to the following: cirrhosis, severe metabolic disease, severe renal failure, severe lung disease, severe neuro/psychiatric disease, muscle disease, etc.
  • Subjects who have any clinically significant cardiovascular diseases
  • Subjects who have thyroid diseases including hyperthyroidism and hypothyroidism
  • Subjects who have a history of immune diseases
  • Subjects who had bariatric surgery within 6 months prior to screening
  • Subjects who had liver transplant surgery
  • Subjects who have a diagnosis of HIV infection
  • Subjects who have a history of chronic infections or have severe or life-threatening infections, or symptoms that may be considered related to infections
  • Subjects diagnosed with a malignant tumor without complete cure within 5 years prior to screening

  • Subjects whose medication history includes any of the following drugs, within a period of 5 times the half-life of the respective drug prior to screening:

    • Therapeutics agents for steatohepatitis: thiazolidinediones, high-dose vitamin E (800 IU/day), pentoxifylline
    • Medications possibly related to PSC: high-dose ursodeoxycholic acid (UDCA; doses smaller than 23 mg/kg/day may be permitted if administered stably without change in dosage from 3 months prior to screening), immunosuppressants, obeticholic acid (OCA), azathioprine, budesonide, docosahexaenoic acid, methotrexate, metronidazole, minocycline, mycophenolate mofetil, nicotine, pentoxifylline, pirfenidone, prednisolone, systemic glucocorticoids, tacrolimus, vancomycin
  • Subjects who administered herbal medicine or folk remedies to improve fatty liver disease within 2 weeks prior to screening
  • Subjects who have a history of alcohol or drug abuse within 5 years prior to screening
  • Subjects who have a hypersensitivity to any excipients of the study drug
  • Subjects who participated in another drug trial within 30 days prior to screening
  • Subjects who are considered inappropriate to participate in clinical trials at the discretion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HK-660S
Oral administration of HK-660S 100 mg (1 tablet) twice daily before morning and evening meals
Drug: HK-660S
Administered orally
Placebo Comparator: Placebo
Oral administration of placebo 1 tablet twice daily before morning and evening meals
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MRCP
Time Frame: Week 12 from baseline
Percentage of subjects who show improvement of severity of PSC as assessed by MRCP with improvement defined as a decrease of -1 or more in the MRCP score
Week 12 from baseline
ALP
Time Frame: Week 12 from baseline
Change of ALP level
Week 12 from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CuromeBiosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Do-hyun Park, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HK-660S-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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