Pilot Study To Assess CAT-2003 in Patients With Chylomicr... | NCT02098278

Studies
Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia

NCT02098278

Sponsor

Catabasis Pharmaceuticals

Status

Completed

Last Update Posted

Jul 21, 2016Estimated

Enrollment

13Actual

Phase

Phase 2

Conditions

Lipoprotein Lipase Deficiency, Familial
Hyperlipoproteinemia Type I
Chylomicronemia, Familial
Hypertriglyceridemia

Interventions

CAT-2003
Placebo

Countries

Canada

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 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Mar 24, 2014

First Submission Date that Met QC Criteria

Mar 27, 2014

First Posted Date

Mar 28, 2014Estimated

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

Jul 19, 2016

Certification/Extension First Submitted that Passed QC Review

Jul 19, 2016

Certification/Extension First Posted Date

Jul 21, 2016Estimated

Last Update Submitted Date

Jul 19, 2016

Last Update Posted Date

Jul 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride clearance.

This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.

Detailed Description

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

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAT-2003 or Placebo	Experimental	All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.	Drug: CAT-2003 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAT-2003	Drug		CAT-2003 or Placebo
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change from baseline in fasting triglycerides in patients with chylomicronemia		12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels		12 Weeks
Absolute and percent change from baseline on chylomicron triglyceride clearance		12 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Familial Chylomicronemia (Fasting triglycerides ≥ 880 mg/dL at Screening and documented history of plasma post-heparin LDL activity < 20% of normal or genetic confirmation of homozygosity or compound heterozygosity for loss-of-function mutations in familial chylomicronemia-causing genes) OR
Non-familial Chylomicronemia (Fasting triglycerides ≥ 440 mg/dL at Screening and documented history of fasting triglycerides ≥ 880 mg/dL)

Key Exclusion Criteria:

History of any major cardiovascular event within 6 months of Screening
Type I diabetes mellitus or use of insulin
History of pancreatitis within 3 month of Screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Chicoutimi	Quebec	G7H 7K9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D008072	Hyperlipoproteinemia Type I
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided