IGF-1 Therapy in Patients With Cystic Fibrosis

This study has been terminated.

(Insufficient recruitment)

Sponsor:

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

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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: Body Weight Cystic Fibrosis

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

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 ]


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 Other Name: 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
Genders Eligible for Study:	Both
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

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

Additional Information:

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

No publications provided


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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stony Brook University:


Body weight Body composition Pulmonary function Carbohydrate tolerance

Additional relevant MeSH terms:


Cystic Fibrosis Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases	Lung Diseases Pancreatic Diseases Pathologic Processes Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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