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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 19, 2014
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases