A Study of HTD1801 in Adolescents With Primary Sclerosing... | NCT03678480

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

NCT03678480

Sponsor

HighTide Biopharma Pty Ltd

Status

Withdrawn

Last Update Posted

Feb 15, 2021Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

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

Interventions

HTD1801
Ursodeoxycholic Acid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Corporate decision

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Oct 4, 2021Estimated

Completion Date

Nov 4, 2021Estimated

First Submitted Date

Sep 18, 2018

First Submission Date that Met QC Criteria

Sep 18, 2018

First Posted Date

Sep 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2021

Last Update Posted Date

Feb 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HTD1801 500 mg BID (twice daily), or 1000 mg/day	Experimental	HTD1801 tablets in double-blind capsules, 250 mg	Drug: HTD1801
Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day	Active Comparator	UDCA tablets in double-blind capsules, 250 mg	Drug: Ursodeoxycholic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HTD1801	Drug	HTD1801 capsules, 250mg	HTD1801 500 mg BID (twice daily), or 1000 mg/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in gamma-glutamyl transferase (GGT)		18 weeks

Secondary Outcomes

Measure	Description	Time Frame
percentage of patients whose GGT normalizes to <50 units/liter		18 weeks
change in aspartate aminotransferase (AST)		18 weeks
change in alanine aminotransferase (ALT)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015209	Cholangitis, Sclerosing
D002761	Cholangitis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014580	Ursodeoxycholic Acid

Ancestor Terms

ID	Term
D003840	Deoxycholic Acid
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided