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Trial record 15 of 29 for:    Recruiting, Not yet recruiting Studies | Primary Sclerosing Cholangitis

A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

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ClinicalTrials.gov Identifier: NCT03678480
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
HighTide Biopharma Pty Ltd

Brief Summary:
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Adolescent Drug: HTD1801 Drug: Ursodeoxycholic Acid Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 4, 2019
Estimated Study Completion Date : November 4, 2019


Arm Intervention/treatment
Experimental: HTD1801 500 mg BID (twice daily), or 1000 mg/day
HTD1801 tablets in double-blind capsules, 250 mg
Drug: HTD1801
HTD1801 capsules, 250mg

Active Comparator: Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day
UDCA tablets in double-blind capsules, 250 mg
Drug: Ursodeoxycholic Acid
UDCA capsules, 125mg




Primary Outcome Measures :
  1. change in gamma-glutamyl transferase (GGT) [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. percentage of patients whose GGT normalizes to <50 units/liter [ Time Frame: 18 weeks ]
  2. change in aspartate aminotransferase (AST) [ Time Frame: 18 weeks ]
  3. change in alanine aminotransferase (ALT) [ Time Frame: 18 weeks ]
  4. change in alkaline phosphatase (ALP) [ Time Frame: 18 weeks ]
  5. change in total bilirubin [ Time Frame: 18 weeks ]
  6. change in C-reactive protein (CRP) [ Time Frame: 18 weeks ]
  7. incidence of adverse events [ Time Frame: 18 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight ≥ 35 kg
  • Previous cholangiographic evidence of PSC by magnetic resonance cholangiopancreatography (MRCP) or direct cholangiography or liver biopsy findings
  • Serum GGT ≥ 2 × upper limit of normal (ULN)
  • On a stable UDCA treatment regimen for ≥ 8 weeks

Exclusion Criteria:

  • Secondary sclerosing cholangitis
  • Percutaneous or endoscopically-placed biliary drain or stent
  • History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year
  • Ascending cholangitis requiring intravenous antibiotic therapy within 60 days prior to Screening
  • Concomitant overlap syndrome with primary biliary cholangitis (PBC)
  • Significant hepatic decompensation
  • Alternative causes of chronic liver disease
  • Hospitalization for colitis within 30 days prior to Screening
  • Serum creatinine > 1.2 x ULN
  • Hemoglobin < 10 g/dL
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678480


Contacts
Contact: S Gamble, PhD 301-801-8815 clinical.trials@hightidebio.com

Sponsors and Collaborators
HighTide Biopharma Pty Ltd

Responsible Party: HighTide Biopharma Pty Ltd
ClinicalTrials.gov Identifier: NCT03678480     History of Changes
Other Study ID Numbers: HTD1801.PCT006
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Digestive System Diseases
Gastrointestinal Diseases
Biliary Tract Diseases
Bile Duct Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents