CClinicalTrials.gg
Sign In
TerminatedNCT00566241Updated Jan 28, 2013

IGF-1 Therapy in Patients With Cystic Fibrosis

A Phase 1 interventional study of recombinant human IGF-1 and Placebo in Cystic Fibrosis, sponsored by Stony Brook University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-28.

Sponsored by Stony Brook University · Phase 1, Interventional, and Treatment

Why this study was terminated
Insufficient recruitment
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.

Read the detailed description

28 week, double blind, cross over study to determine the efficacy of rhIGF-1 on body weight and body composition in patients with cystic fibrosis.

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • Body weight
  • Body composition
  • Pulmonary function
  • Carbohydrate tolerance
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 15 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

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
No

Inclusion criteria

  • Diagnosis of cystic fibrosis as proven by either sweat chloride or DNA analysis.
  • Age >= 18 yr.
  • Tanner stage: Femake Breasts: 4-5 Male Genitalia: 4-5

Exclusion criteria

Exclusion criteria:

  • Hemoglobin A1C > 8.5 %
  • Diabetic retinopathy
  • Obstructive sleep apnea
  • Respiratory failure requiring mechanical ventilation.
  • Status post pulmonary transplantation.
  • Concurrent or recent (within past 6 months) receipt of human growth hormone.
  • History of adverse side effects to growth hormone other than carbohydrate intolerance.
  • Pregnancy or attempting pregnancy.
  • Women who are breast feeding.
  • Sexually active women who refuse to use or are incapable of responsibly using reliable contraception.
  • Proven non compliance with medical regimens.
  • Inability or refusal to take subcutaneous injections.
  • Known allergy to components in the IGF-I preparation.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    IGF-1

    Recombinant human IGF-1

    Drug: recombinant human IGF-1

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • Drugrecombinant human IGF-1

    rhIGF-1

    Also known as: mecasermin

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Body weight and body composition

    Time frame: 28 weeks

Secondary outcomes

  1. Pulmonary function

    Time frame: 28 weeks

  2. Carbohydrate tolerance

    Time frame: 28 weeks

07

Study locations

1 site
  • State University of New York
    Stony Brook, New York 11794-8333, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00566241
Lead sponsor
Stony Brook University
Responsible party
Thomas A. Wilson (Professor of Pediatrics, Stony Brook University) — Principal investigator
First posted
Dec 3, 2007
Start date
Jun 2008
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jan 28, 2013

Study contacts

Thomas A Wilson, MD
principal investigator · State Univeristy of New York, Stony Brook, NY

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cystic Fibrosis→

Other studies from this sponsor

Stony Brook University

Start the discussion