Primary Sclerosing CholangitisPhase 2NCT05866809
Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis
A Phase 2 study testing HK-660S in people with Primary Sclerosing Cholangitis, run by CuromeBiosciences at 4 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- HK-660S
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 28 Oct 2021to 24 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 26Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Hospital
Seoul, 02080
Severance Hospital
Seoul, 03722
ASAN Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- HK-660S, Placebo
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HK-660SDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| HK-660S | Experimental | Oral administration of HK-660S 100 mg (1 tablet) twice daily before morning and evening meals Receives: Drug: HK-660S |
| Placebo | Placebo comparator | Oral administration of placebo 1 tablet twice daily before morning and evening meals Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRCP
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
Measured: Week 12 from baseline
ALP
Change of ALP level
Measured: Week 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start28 Oct 2021
- Primary completion23 Jun 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- CuromeBiosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Do-hyun Park, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866809
- Sponsor's protocol ID
- HK-660S-201
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05866809
- Acronym / sponsor ID
- HK-660S-201
- Conditions
- Primary Sclerosing Cholangitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- CuromeBiosciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HK-660S | Experimental | Drug: HK-660SOral administration of HK-660S 100 mg (1 tablet) twice daily before morning and evening meals |
| Placebo | Placebo comparator | Drug: PlaceboOral administration of placebo 1 tablet twice daily before morning and evening meals |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HK-660SAdministered orally | Drug | HK-660S |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
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
ALP
Time frame: Week 12 from baseline
Change of ALP level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Do-hyun Park principal investigator
Asan Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HK-660S in people with Primary Sclerosing Cholangitis, run by CuromeBiosciences at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRCP (time frame: Week 12 from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.