IGF-1 Therapy in Patients With Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT00566241 |
Recruitment Status :
Terminated
(Insufficient recruitment)
First Posted : December 3, 2007
Last Update Posted : January 28, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: recombinant human IGF-1 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: IGF-1
Recombinant human IGF-1
|
Drug: recombinant human IGF-1
rhIGF-1
Other Name: mecasermin |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo |
- Body weight and body composition [ Time Frame: 28 weeks ]
- Pulmonary function [ Time Frame: 28 weeks ]
- Carbohydrate tolerance [ Time Frame: 28 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566241
United States, New York | |
State University of New York | |
Stony Brook, New York, United States, 11794-8333 |
Principal Investigator: | Thomas A Wilson, MD | State Univeristy of New York, Stony Brook, NY |
Responsible Party: | Thomas A. Wilson, Professor of Pediatrics, Stony Brook University |
ClinicalTrials.gov Identifier: | NCT00566241 |
Other Study ID Numbers: |
IGF-1 in Cystic Fibrosis |
First Posted: | December 3, 2007 Key Record Dates |
Last Update Posted: | January 28, 2013 |
Last Verified: | January 2013 |
Body weight Body composition Pulmonary function Carbohydrate tolerance |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Mecasermin Growth Substances Physiological Effects of Drugs |