A POC and Dose-Ranging Study of HTD1801 in PSC Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis (PSC)

In brief

The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.

Key facts

Study ID

NCT03333928

Run by

HighTide Biopharma Pty Ltd

People needed

59

Starts

2018-02-09

Expected to finish

2020-08-14

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 18 and 75 years of age;
• Have a clinical diagnosis of PSC as evident by chronic cholestasis of more than six months duration with either a consistent magnetic resonance cholangiopancreatography (MRCP)/endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis;
• If subjects have Inflammatory Bowel Disease (IBD) they will be eligible to participate. If a subject has IBD, documented evidence of IBD must have been evident by prior endoscopy or in previous medical records for ≥6 months. In addition, subjects may only enter the study with a Partial Mayo Score of 0-4, inclusively. Subjects who are on treatment are allowed, provided they are stable for 3 months if taking:
• 5-amino salicylic acid drugs,
• azathioprine,
• 6-mercaptopurine, or methotrexate
• biologics;
• Have a serum ALP ≥1.5 × upper limit of normal (ULN);
• Be able to understand and sign a written informed consent form (ICF);
• Subjects receiving allowed concomitant medications need to be on stable therapy for 28 days prior to the Baseline visit, with the exception of ursodeoxycholic acid (UDCA), which should be stable for at least 6 weeks prior to the Baseline visit.

You may not qualify if…

• Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations;
• Small duct PSC;
• Presence of percutaneous drain or bile duct stent;
• History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year by MRCP/ERCP. Presence of dominant stricture without ERCP evidence of cholangiocarcinoma is acceptable if stable for ≥ 1 year;
• Ascending cholangitis within 60 days prior to Screening;
• History of alcohol or substance abuse or dependence;
• Prior or planned liver transplantation;
• Presence of alternative causes of chronic liver disease, including alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, autoimmune hepatitis;
• Platelet count below 125,000/mm3, albumin below 3.0 g/dL, International Normalized Ratio (INR) > 1.2, or a history of ascites, or encephalopathy, or history of esophageal variceal bleeding;
• Severe active IBD or flare in colitis activity within the last 90 days requiring intensification of therapy beyond baseline treatment;

Where it is running

• Arizona Liver Health — Chandler, Arizona, United States
• Arizona Liver Health — Tuscon, Arizona, United States
• Fresno Clinical Research Center — Fresno, California, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• South Denver Gastroenterology, PC — Englewood, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• University of Miami — Miami, Florida, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Michigan Medicine University of Michigan — Ann Arbor, Michigan, United States
• Gastrointestinal Associates — Flowood, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai - Icahn School of Medicine — New York, New York, United States
• Cumberland Research Associates — Fayetteville, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Gastro One — Germantown, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Pinnacle Clinical Research — Austin, Texas, United States
• Pinnacle Clinical Research — San Antonio, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• University of Washington — Seattle, Washington, United States
• Aspen Woods Clinic — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.