Trial Outcomes & Findings for Effect of Increlex® on Children With Crohn Disease (NCT NCT00764699)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

3 participants

Primary outcome timeframe

Six months and 1 year

Results posted on

2018-03-02

Participant milestones
Measure	rhIGF Treatment 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.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	rhIGF Treatment 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.
Overall Study PI left and study terminated	3

Effect of Increlex® on Children With Crohn Disease

Baseline characteristics by cohort
Measure	rhIGF n=3 Participants Treatment 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.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	12.67 years STANDARD_DEVIATION 2.52 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

Timeframe: Six months and 1 year

Population: The PI left the institution suddenly and participant records stayed with the institution, so no analysis was able to be performed.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Nationwide Children's Hospital

Phone: 6143553142