IGF-1 Therapy in Patients With Cystic Fibrosis

Stony Brook University

Status and phase: Terminated; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: recombinant human IGF-1; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00566241

IGF-1 in Cystic Fibrosis

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

IGF-1

Experimental group

Description:

Recombinant human IGF-1

Treatment:

Drug: recombinant human IGF-1

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo