IGF-1 Therapy in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00566241
• Other study ID #: IGF-1 in Cystic Fibrosis
• Status: Terminated
• Phase: Phase 1
• First received: November 30, 2007
• Last updated: January 25, 2013
• Start date: June 2008
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• recombinant human IGF-1
rhIGF-1
• Placebo
Placebo

Locations

Country	Name	City	State
United States	State University of New York	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight and body composition		28 weeks	Yes
Secondary	Pulmonary function		28 weeks	Yes
Secondary	Carbohydrate tolerance		28 weeks	Yes