IGF-1 Therapy in Patients With Cystic Fibrosis

January 25, 2013 updated by: Thomas A. Wilson, Stony Brook University

An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis

28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794-8333
        • State University of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: IGF-1
Recombinant human IGF-1
Drug: recombinant human IGF-1
rhIGF-1
Other Names:
  • mecasermin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight and body composition
Time Frame: 28 weeks
28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function
Time Frame: 28 weeks
28 weeks
Carbohydrate tolerance
Time Frame: 28 weeks
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Thomas A Wilson, MD, State Univeristy of New York, Stony Brook, NY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimate)

December 3, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGF-1 in Cystic Fibrosis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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