Apolipoprotein CIII Reduction Via Colchicine

NCT02083510 | Completed Early Phase 1

• 2 other identifiers: 13-62931UL1TR001114-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia; Gout; Pericarditis

Keywords

Colchicine; Hypertriglyceridemia; Apolipoprotein CIII

Outcome Measures

Primary Outcomes (2)

• Reduction in ApoCIII levels

  6 weeks

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

  6 weeks

Secondary Outcomes (1)

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

  6 weeks

Study Arms (1)

Colchicine

EXPERIMENTAL

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

Colchicine DRUG

Also known as: Colcrys

Colchicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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
• st metatarsal joint painful or swollen

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

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Gout; Pericarditis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Peter Schultz, PhD

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 11, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

US (1)