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
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:
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 July 20, 2014