IGF-1 Therapy in Patients With Cystic Fibrosis

NCT ID: NCT00566241

Last Updated: 2013-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IGF-1

Recombinant human IGF-1

Group Type EXPERIMENTAL

recombinant human IGF-1

Intervention Type DRUG

rhIGF-1

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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recombinant human IGF-1

rhIGF-1

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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mecasermin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Thomas A. Wilson

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas A Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

State Univeristy of New York, Stony Brook, NY

Locations

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State University of New York

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IGF-1 in Cystic Fibrosis

Identifier Type: -

Identifier Source: org_study_id

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