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CompletedNCT02083510Updated May 30, 2014

Apolipoprotein CIII Reduction Via Colchicine

An Early Phase 1 interventional study of Colchicine in Hypertriglyceridemia, Gout and Pericarditis, sponsored by Scripps Translational Science Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-30.

Sponsored by Scripps Translational Science Institute · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Hypertriglyceridemia
  • Gout
  • Pericarditis

Keywords

  • Colchicine
  • Hypertriglyceridemia
  • Apolipoprotein CIII
03

In context

Pericarditis

58 studies on the registry are indexed under Pericarditis; 23 are open to participants now.

This study's enrollment of 5 is below the median of 55 across 28 interventional studies indexed under Pericarditis.

Browse Pericarditis studies →

Lead sponsor

Scripps Translational Science Institute is the lead sponsor of 52 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Colchicine

    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.

    Drug: Colchicine

Interventions

  • DrugColchicine

    Also known as: Colcrys

06

What researchers measure

Primary outcomes

  1. Reduction in ApoCIII levels

    Time frame: 6 weeks

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

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

07

Study locations

1 site
  • Scripps Translational Science Institute
    La Jolla, California 92037, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02083510
Lead sponsor
Scripps Translational Science Institute
Responsible party
Peter G. Schultz, PhD (Prinicpal Investigator, The Scripps Research Institute) — Principal investigator
First posted
Mar 11, 2014
Start date
Feb 2014
Primary completion
May 2014
Completion
May 2014
Last update
May 30, 2014

Study contacts

Peter Schultz, PhD
principal investigator · Scripps Translational Science Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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