Status:
COMPLETED
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
Lead Sponsor:
HighTide Biopharma Pty Ltd
Conditions:
Primary Sclerosing Cholangitis (PSC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03333928
Start Date
February 9 2018
End Date
August 14 2020
Last Update
October 23 2025
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Liver Health
Chandler, Arizona, United States, 85224
2
Arizona Liver Health
Tuscon, Arizona, United States, 85711
3
Fresno Clinical Research Center
Fresno, California, United States, 93720
4
Keck School of Medicine of USC
Los Angeles, California, United States, 90033