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IGF-1 Therapy in Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant human IGF-1
Placebo
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Body weight, Body composition, Pulmonary function, Carbohydrate tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • State University of New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IGF-1

Placebo

Arm Description

Recombinant human IGF-1

Placebo

Outcomes

Primary Outcome Measures

Body weight and body composition

Secondary Outcome Measures

Pulmonary function
Carbohydrate tolerance

Full Information

First Posted
November 30, 2007
Last Updated
January 25, 2013
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT00566241
Brief Title
IGF-1 Therapy in Patients With Cystic Fibrosis
Official Title
An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Body weight, Body composition, Pulmonary function, Carbohydrate tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IGF-1
Arm Type
Experimental
Arm Description
Recombinant human IGF-1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
recombinant human IGF-1
Other Intervention Name(s)
mecasermin
Intervention Description
rhIGF-1
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Body weight and body composition
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Pulmonary function
Time Frame
28 weeks
Title
Carbohydrate tolerance
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Wilson, MD
Organizational Affiliation
State Univeristy of New York, Stony Brook, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8333
Country
United States

12. IPD Sharing Statement

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IGF-1 Therapy in Patients With Cystic Fibrosis

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