IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
IGF-1 Therapy in Patients With Cystic Fibrosis
This study has been terminated.
(Insufficient recruitment)
Sponsor:
Stony Brook University
Information provided by (Responsible Party):
Thomas A. Wilson, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00566241
First received: November 30, 2007
Last updated: January 25, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: recombinant human IGF-1 Drug: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
U.S. FDA Resources
Further study details as provided by Thomas A. Wilson, Stony Brook University:
Primary Outcome Measures:
- Body weight and body composition [ Time Frame: 28 weeks ]
Secondary Outcome Measures:
- Pulmonary function [ Time Frame: 28 weeks ]
- Carbohydrate tolerance [ Time Frame: 28 weeks ]
| Enrollment: | 15 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IGF-1
Recombinant human IGF-1
|
Drug: recombinant human IGF-1
rhIGF-1
Other Name: mecasermin
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566241
Locations
| United States, New York | |
| State University of New York | |
| Stony Brook, New York, United States, 11794-8333 | |
Sponsors and Collaborators
Stony Brook University
Investigators
| Principal Investigator: | Thomas A Wilson, MD | State Univeristy of New York, Stony Brook, NY |
More Information
| Responsible Party: | Thomas A. Wilson, Professor of Pediatrics, Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT00566241 History of Changes |
| Other Study ID Numbers: |
IGF-1 in Cystic Fibrosis |
| Study First Received: | November 30, 2007 |
| Last Updated: | January 25, 2013 |
Keywords provided by Thomas A. Wilson, Stony Brook University:
|
Body weight Body composition Pulmonary function Carbohydrate tolerance |
Additional relevant MeSH terms:
|
Fibrosis Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on June 22, 2017