IGF-1 Therapy in Patients With Cystic Fibrosis

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Treatments: Mecasermin

Criteria

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.