Apolipoprotein CIII Reduction Via Colchicine

Completed · Early Phase 1

Conditions studied: Hypertriglyceridemia, Gout, Pericarditis

In brief

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.

Key facts

Study ID

NCT02083510

Run by

Scripps Translational Science Institute

People needed

5

Starts

2014-02-01

Expected to finish

2014-05-01

Last updated by the study team

2014-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Translational Science Institute — La Jolla, California, United States

Full record on ClinicalTrials.gov

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