IGF-1 Therapy in Patients With Cystic Fibrosis
This study has been terminated.
Information provided by (Responsible Party):
Thomas A. Wilson, Stony Brook University
First received: November 30, 2007
Last updated: January 25, 2013
Last verified: January 2013
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.
Drug: recombinant human IGF-1
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis
Primary Outcome Measures:
- Body weight and body composition [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pulmonary function [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
- Carbohydrate tolerance [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
Recombinant human IGF-1
Drug: recombinant human IGF-1
Other Name: mecasermin
Placebo Comparator: Placebo
Other Name: Placebo
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566241
|State University of New York
|Stony Brook, New York, United States, 11794-8333 |
Stony Brook University
||Thomas A Wilson, MD
||State Univeristy of New York, Stony Brook, NY
No publications provided
||Thomas A. Wilson, Professor of Pediatrics, Stony Brook University
History of Changes
|Other Study ID Numbers:
||IGF-1 in Cystic Fibrosis
|Study First Received:
||November 30, 2007
||January 25, 2013
||United States: Food and Drug Administration
Keywords provided by Stony Brook University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases