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HypertriglyceridemiaEarly Phase 1NCT02083510

Apolipoprotein CIII Reduction Via Colchicine

A Early Phase 1 study testing Colchicine in people with Hypertriglyceridemia and Gout, run by Scripps Translational Science Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertriglyceridemia, Gout, Pericarditis
What is being tested?
Colchicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Feb 2014to May 2014
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 31Show fewer
  • •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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Scripps Translational Science Institute

    La Jolla, California, 92037

Other trials in United States

About this study

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

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).

Being tested
Colchicine
Keywords
Colchicine, Hypertriglyceridemia, Apolipoprotein CIII
Medical subject headings
Hypertriglyceridemia, Gout, Pericarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    Also called Colcrys

Study groups in NCT02083510
Study groupRoleWhat they receive
ColchicineExperimentalPatients 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.
Receives: Drug: Colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in ApoCIII levels

    Measured: 6 weeks

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

    Measured: 6 weeks

Secondary outcomes (1)

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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02083510
Sponsor's protocol ID
13-6293
Other IDs
1UL1TR001114-01
Status last verified
May 2014
First submitted
5 Mar 2014
Last updated
30 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Colchicine in people with Hypertriglyceridemia and Gout, run by Scripps Translational Science Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in ApoCIII levels (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02083510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.

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