IGF-1 Therapy in Patients With Cystic Fibrosis

NCT00566241 | Terminated Phase 1 DMC

• 1 other identifier: IGF-1 in Cystic Fibrosis
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Body weight; Body composition; Pulmonary function; Carbohydrate tolerance

Outcome Measures

Primary Outcomes (1)

• Body weight and body composition

  28 weeks

Secondary Outcomes (2)

• Pulmonary function

  28 weeks

• Carbohydrate tolerance

  28 weeks

Study Arms (2)

IGF-1

EXPERIMENTAL

Recombinant human IGF-1

Drug: recombinant human IGF-1

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

recombinant human IGF-1 DRUG

rhIGF-1

Also known as: mecasermin

IGF-1

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

State University of New York

Stony Brook, New York, 11794-8333, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Body Weight

Interventions

mecasermin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas A Wilson, MD

  State Univeristy of New York, Stony Brook, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: June 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (1)