IGF-1 Therapy in Patients With Cystic Fibrosis
Phase 1
Terminated
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: recombinant human IGF-1Drug: Placebo
- Registration Number
- NCT00566241
- Lead Sponsor
- Stony Brook University
- Brief Summary
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IGF-1 recombinant human IGF-1 Recombinant human IGF-1 Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Body weight and body composition 28 weeks
- Secondary Outcome Measures
Name Time Method Pulmonary function 28 weeks Carbohydrate tolerance 28 weeks
Trial Locations
- Locations (1)
State University of New York
🇺🇸Stony Brook, New York, United States