Back to results

Apolipoprotein CIII Reduction Via Colchicine

Primary Purpose

Hypertriglyceridemia, Gout, Pericarditis

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Colchicine

About this trial

This is an interventional basic science trial for Hypertriglyceridemia focused on measuring Colchicine, Hypertriglyceridemia, Apolipoprotein CIII

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Acute new-onset pericarditis or recurrent pericarditis (≥2 following criteria)
- Sharp and pleuritic chest pain improved or relieved by sitting up and leaning forward
- A pericardial friction rub
- Electrocardiogram (EKG) findings of diffuse ST-segment elevations or PR depression
- New or worsening pericardial effusion visualized on echocardiogram.

•Acute gouty arthritis (according to the ACR; ≥1 of following criteria:

Joint fluid containing urate crystals
Tophus proved to contain urate crystals by chemical means
Polarized light microscopy
Presence of six of the following in the absence of crystal identification:
>1 attack of acute arthritis
Maximum inflammation developed in 1 day
Monoarthritis attack
Redness observed over joints
1st metatarsal joint painful or swollen
Unilateral 1st metatarsal joint attack
Unilateral tarsal joint attack
Tophus (suspected)
Hyperuricemia
Asymmetric swelling within a joint visible on physical examination or radiography
Subcortical cysts without erosions visible on radiography
Monosodium urate monohydrate microcrystals in joint fluid during attack
Joint fluid culture negative for organisms during attack.

If N < 10 after 3 weeks of trial initiation, then employ enrollment strategy #2

Enrollment strategy #2:

History of hypertriglyceridemia (TG ≥ 150 mg/dL) AND
Age ≥ 18 years old
Capable of providing informed consent
Capable of taking Colchicine 0.6-1.2 mg/day orally for 6 weeks
Capable of providing a blood sample

Exclusion Criteria:

Colchicine use < 8 weeks from baseline VAP panel
Pregnant or female of child bearing age
On corticosteroid therapy or corticosteroid use < 4 weeks from baseline VAP panel
History of statin myopathy or hepatotoxicity
History of colchicine intolerance or hypersensitivity
Severe end-stage renal disease (eGFR ≤ 20 mL/min/1.73 m2) or requiring dialysis
Hepatic Impairment (Child-Pugh class B or C)
Myopericarditis (If TnI is elevated on presentation of acute pericarditis)
Inflammatory Bowel Disease
Tuberculous, neoplastic, or purulent pericarditis

Sites / Locations

Scripps Translational Science Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colchicine

Arm Description

Patients will be enrolled with either gout/pericarditis or hypertriglyceridemia, have VAP and Apolipoprotein CIII levels at baseline, administer Colchicine for 6 weeks with reassessment of Apolipoprotein CIII and VAP.

Outcomes

Primary Outcome Measures

Reduction in ApoCIII levels

Reduction of triglycerides and very low density lipoprotein (VLDL) levels

Secondary Outcome Measures

Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP)

Full Information

NCT ID

NCT02083510

First Posted

March 5, 2014

Last Updated

May 28, 2014

Sponsor

Scripps Translational Science Institute

1. Study Identification

Unique Protocol Identification Number

NCT02083510

Brief Title

Apolipoprotein CIII Reduction Via Colchicine

Official Title

A Translational Study to Understand the Mechanism of Apolipoprotein CIII Reduction Via Colchicine

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Scripps Translational Science Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this trial will be to determine an effect-size for the administration of chronic low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density lipoproteins (VLDL), and apolipoprotein CIII (apoCIII) in human subjects over a period of 4-6 weeks.

Detailed Description

The aim of this proposal will be to show, in a translational fashion, a relationship between colchicine and reduction of factors affecting triglyceride metabolism, especially apoCIII and VLDL levels. We envision colchicine as playing a role in identifying and elucidating a new mechanism for lowering TG levels, which may have a great impact on targeting patients who have not met non-HDL goals according to Adult Treatment Panel III (ATPIII guidelines) or at risk for hypertriglyceridemia-induced pancreatitis [11]. We will accomplish this by conducting a prospective cohort clinical trial of low-dose colchicine in hypertriglyceridemic patients to assess percent (%) reduction of apoCIII, VLDL, and TG. Secondary endpoints will be to observe the effects of colchicine on apoA, apoB, HDL, low-density lipoprotein (LDL), and total cholesterol (TC).

6. Conditions and Keywords

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

Hypertriglyceridemia, Gout, Pericarditis

Keywords

Colchicine, Hypertriglyceridemia, Apolipoprotein CIII

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colchicine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Colchicine

Other Intervention Name(s)

Colcrys

Primary Outcome Measure Information:

Title

Reduction in ApoCIII levels

Time Frame

6 weeks

Title

Reduction of triglycerides and very low density lipoprotein (VLDL) levels

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP)

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Acute new-onset pericarditis or recurrent pericarditis (≥2 following criteria) Sharp and pleuritic chest pain improved or relieved by sitting up and leaning forward A pericardial friction rub Electrocardiogram (EKG) findings of diffuse ST-segment elevations or PR depression New or worsening pericardial effusion visualized on echocardiogram. OR •Acute gouty arthritis (according to the ACR; ≥1 of following criteria: Joint fluid containing urate crystals Tophus proved to contain urate crystals by chemical means Polarized light microscopy Presence of six of the following in the absence of crystal identification: >1 attack of acute arthritis Maximum inflammation developed in 1 day Monoarthritis attack Redness observed over joints 1st metatarsal joint painful or swollen Unilateral 1st metatarsal joint attack Unilateral tarsal joint attack Tophus (suspected) Hyperuricemia Asymmetric swelling within a joint visible on physical examination or radiography Subcortical cysts without erosions visible on radiography Monosodium urate monohydrate microcrystals in joint fluid during attack Joint fluid culture negative for organisms during attack. If N < 10 after 3 weeks of trial initiation, then employ enrollment strategy #2 Enrollment strategy #2: History of hypertriglyceridemia (TG ≥ 150 mg/dL) AND Age ≥ 18 years old Capable of providing informed consent Capable of taking Colchicine 0.6-1.2 mg/day orally for 6 weeks Capable of providing a blood sample Exclusion Criteria: Colchicine use < 8 weeks from baseline VAP panel Pregnant or female of child bearing age On corticosteroid therapy or corticosteroid use < 4 weeks from baseline VAP panel History of statin myopathy or hepatotoxicity History of colchicine intolerance or hypersensitivity Severe end-stage renal disease (eGFR ≤ 20 mL/min/1.73 m2) or requiring dialysis Hepatic Impairment (Child-Pugh class B or C) Myopericarditis (If TnI is elevated on presentation of acute pericarditis) Inflammatory Bowel Disease Tuberculous, neoplastic, or purulent pericarditis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Schultz, PhD

Organizational Affiliation

Scripps Translational Science Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scripps Translational Science Institute

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Apolipoprotein CIII Reduction Via Colchicine

We'll reach out to this number within 24 hrs