IGF-1 Therapy in Patients With Cystic Fibrosis | NCT00566241

Studies
IGF-1 Therapy in Patients With Cystic Fibrosis

NCT00566241

Sponsor

Stony Brook University

Status

Terminated

Last Update Posted

Jan 28, 2013Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Cystic Fibrosis

Interventions

recombinant human IGF-1
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Nov 30, 2007

First Submission Date that Met QC Criteria

Nov 30, 2007

First Posted Date

Dec 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2013

Last Update Posted Date

Jan 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IGF-1	Experimental	Recombinant human IGF-1	Drug: recombinant human IGF-1
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
recombinant human IGF-1	Drug	rhIGF-1	IGF-1	mecasermin

Measure	Description	Time Frame
Body weight and body composition		28 weeks

Measure	Description	Time Frame
Pulmonary function		28 weeks
Carbohydrate tolerance		28 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas A Wilson, MD	State Univeristy of New York, Stony Brook, NY	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State University of New York		Stony Brook	New York	11794-8333	United States

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D001835	Body Weight

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000604197	mecasermin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided