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IGF-1 Therapy in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00566241
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : December 3, 2007
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
Thomas A. Wilson, Stony Brook University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: recombinant human IGF-1 Drug: Placebo Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (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
Study Start Date : June 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: IGF-1
Recombinant human IGF-1
 Drug: recombinant human IGF-1
rhIGF-1
Other Name: mecasermin
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Body weight and body composition [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: 28 weeks ]
  2. Carbohydrate tolerance [ Time Frame: 28 weeks ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 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
Mecasermin
Growth Substances
Physiological Effects of Drugs