Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03678480
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
HighTide Biopharma Pty Ltd

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 19, 2018
Last Update Posted Date February 26, 2019
Estimated Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date October 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
change in gamma-glutamyl transferase (GGT) [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03678480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • percentage of patients whose GGT normalizes to <50 units/liter [ Time Frame: 18 weeks ]
  • change in aspartate aminotransferase (AST) [ Time Frame: 18 weeks ]
  • change in alanine aminotransferase (ALT) [ Time Frame: 18 weeks ]
  • change in alkaline phosphatase (ALP) [ Time Frame: 18 weeks ]
  • change in total bilirubin [ Time Frame: 18 weeks ]
  • change in C-reactive protein (CRP) [ Time Frame: 18 weeks ]
  • incidence of adverse events [ Time Frame: 18 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • normalization of GGT to <50 units/liter [ Time Frame: 18 weeks ]
  • change in aspartate aminotransferase (AST) [ Time Frame: 18 weeks ]
  • change in alanine aminotransferase (ALT) [ Time Frame: 18 weeks ]
  • change in alkaline phosphatase (ALP) [ Time Frame: 18 weeks ]
  • change in total bilirubin [ Time Frame: 18 weeks ]
  • change in C-reactive protein (CRP) [ Time Frame: 18 weeks ]
  • incidence of adverse events [ Time Frame: 18 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
Official Title  ICMJE A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
Brief Summary Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Sclerosing Cholangitis
  • Cholangitis
  • Cholangitis, Sclerosing
  • Bile Duct Diseases
  • Biliary Tract Diseases
  • Digestive System Diseases
  • Adolescent
Intervention  ICMJE
  • Drug: HTD1801
    HTD1801 capsules, 250mg
  • Drug: Ursodeoxycholic Acid
    UDCA capsules, 125mg
Study Arms  ICMJE
  • Experimental: HTD1801 500 mg BID (twice daily), or 1000 mg/day
    HTD1801 tablets in double-blind capsules, 250 mg
    Intervention: Drug: HTD1801
  • Active Comparator: Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day
    UDCA tablets in double-blind capsules, 250 mg
    Intervention: Drug: Ursodeoxycholic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2018)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 4, 2021
Estimated Primary Completion Date October 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: S Gamble, PhD 301-801-8815 clinical.trials@hightidebio.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03678480
Other Study ID Numbers  ICMJE HTD1801.PCT006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HighTide Biopharma Pty Ltd
Study Sponsor  ICMJE HighTide Biopharma Pty Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account HighTide Biopharma Pty Ltd
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP