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

Primary Purpose

Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

HTD1801

Ursodeoxycholic Acid

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HTD1801 500 mg BID (twice daily), or 1000 mg/day

Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day

Arm Description

HTD1801 tablets in double-blind capsules, 250 mg

UDCA tablets in double-blind capsules, 250 mg

Outcomes

Primary Outcome Measures

change in gamma-glutamyl transferase (GGT)

Secondary Outcome Measures

percentage of patients whose GGT normalizes to <50 units/liter

change in aspartate aminotransferase (AST)

change in alanine aminotransferase (ALT)

change in alkaline phosphatase (ALP)

change in total bilirubin

change in C-reactive protein (CRP)

incidence of adverse events

Full Information

NCT ID

NCT03678480

First Posted

September 18, 2018

Last Updated

February 10, 2021

Sponsor

HighTide Biopharma Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03678480

Brief Title

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

Official Title

A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Corporate decision

Study Start Date

March 1, 2021 (Anticipated)

Primary Completion Date

October 4, 2021 (Anticipated)

Study Completion Date

November 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HighTide Biopharma Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases, Adolescent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HTD1801 500 mg BID (twice daily), or 1000 mg/day

Arm Type

Experimental

Arm Description

HTD1801 tablets in double-blind capsules, 250 mg

Arm Title

Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day

Arm Type

Active Comparator

Arm Description

UDCA tablets in double-blind capsules, 250 mg

Intervention Type

Drug

Intervention Name(s)

HTD1801

Intervention Description

HTD1801 capsules, 250mg

Intervention Type

Drug

Intervention Name(s)

Ursodeoxycholic Acid

Intervention Description

UDCA capsules, 125mg

Primary Outcome Measure Information:

Title

change in gamma-glutamyl transferase (GGT)

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

percentage of patients whose GGT normalizes to <50 units/liter

Time Frame

18 weeks

Title

change in aspartate aminotransferase (AST)

Time Frame

18 weeks

Title

change in alanine aminotransferase (ALT)

Time Frame

18 weeks

Title

change in alkaline phosphatase (ALP)

Time Frame

18 weeks

Title

change in total bilirubin

Time Frame

18 weeks

Title

change in C-reactive protein (CRP)

Time Frame

18 weeks

Title

incidence of adverse events

Time Frame

18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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