IGF-1 Therapy in Patients With Cystic Fibrosis - Full Text View

Sponsored by:	Stony Brook University
Information provided by:	Stony Brook University
ClinicalTrials.gov Identifier:	NCT00566241

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 I

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis

Further study details as provided by Stony Brook University:

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 ]

Estimated Enrollment:	15
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010

Arms	Assigned Interventions
IGF-1: Experimental IGF-1 treatment	Drug: recombinant human IGF-1 rhIGF-1
Placebo: Placebo Comparator 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566241

Locations

United States, New York
State University of New York	Recruiting
Stony Brook, New York, United States, 11794-8333
Contact: Thomas A Wilson, MD 631-444-3429 Thomas.A.Wilson@SUNYSB.EDU
Principal Investigator: Thomas A Wilson, MD
Sub-Investigator: Catherine Kier, MD

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator:

Thomas A Wilson, MD

State Univeristy of New York, Stony Brook, NY

More Information

General Clinical Research Center, Stony Brook, NY This link exits the ClinicalTrials.gov site

Responsible Party:	Department of Pediatrics, State University of New York, Stony Brook ( Thomas A. Wilson, MD )
Study ID Numbers:	IGF-1 in Cystic Fibrosis
Study First Received:	November 30, 2007
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00566241
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stony Brook University:

Body weight
Body composition
Pulmonary function
Carbohydrate tolerance

Study placed in the following topic categories:

Body Weight
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009