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
  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:


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

ClinicalTrials.gov processed this record on April 17, 2014