IGF-1 Therapy in Patients With Cystic Fibrosis

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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

Key facts

Study ID

NCT00566241

Run by

Stony Brook University

People needed

15

Starts

2008-06-01

Expected to finish

2012-06-01

Last updated by the study team

2013-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• State University of New York — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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