Trial · Interventional

TerminatedPhase 2/3Results postedRegistry data

Effect of Increlex® on Children With Crohn Disease

NCTNCT00764699Other idIRB08-00213

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: PI left institution

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2/3
Enrollment: 3 participants (actual)
Sponsor: Nationwide Children's Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Oct 2008
Primary completion: May 2010
Completion: May 2010
First posted: 2 Oct 2008 (estimated)
Last update posted: 2 Mar 2018
Conditions: Crohn Disease

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008200920102011

Ph 2/3
Effect of Increlex® on Children With Crohn Disease
NCT00764699
Oct 2008 to May 2010
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Patients with Crohn disease often have poor weight gain and short stature, yet the etiology of the poor growth is not well defined. Studies in chronically ill patients who do not have Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance in chronically ill children, particularly those who require treatment with corticosteroids. Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient short stature. This medication has not been studied in Crohn disease. The purpose of this study is to test the hypothesis that poor growth in Crohn disease is associated abnormal IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test our hypothesis we will recruit 20 patients with Crohn disease from our pediatric gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a minimum of one year and will be studied at baseline and six month intervals for one year while on treatment with Increlex.

Interventions

rhIGF (Increlex)Drug

Arms1

Experimental
rhIGF
Treatment with rhIGF (Increlex)

Primary outcomes1

Outcomes the sponsor listed as primary.

The Primary Outcome Variable for the Monitoring Study (Baseline, Six Months and Disease Exacerbation) Will be Longitudinal Growth as Measured by Height Velocity
Time frame · Six months and 1 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Six months and 1 year

The Primary Outcome Variable for the Monitoring Study (Baseline, Six Months and Disease Exacerbation) Will be Longitudinal Growth as Measured by Height Velocity

Group	Value
rhIGF	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
rhIGFTreatment with rhIGF (Increlex) rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.	–	0 / 3	0 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 5 Years up to 15 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Moderate to severe Crohn Disease (PCDAI \> 30) * Chronological age 5-15 years old * Tanner 1 - 3 * Bone age less than or equal to 13 in females and 14 in males Exclusion Criteria: * Identified infectious etiology * Immunological disorder (excluding Crohn disease) * Associated severe concomitant chronic illnesses (CF, liver failure, etc)

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