At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 82 enrolled

Drug / intervention

Somatropindrug

Likely dose

Somatropin 0.043 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02311894

NCT02311894Phase 4Completed

Compare CT.gov

A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY)

Genentech, Inc.·interventional·Posted Dec 9, 2014·Updated Jan 8, 2019

In Brief

A Phase 4 clinical trial evaluating Somatropin for Growth Hormone Deficiency. Completed, enrolled 82 participants across 33 sites.

Detailed Summary

This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of somatropin (rDNA origin) injection when administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will also be assessed.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGrowth Hormone Deficiency

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

First PostedDec 2014

Enrollment StartMar 2015

Primary CompletionNov 2017

TodayJul 2026

First PostedDec 9, 2014

Enrollment StartMar 31, 2015

Primary CompletionNov 8, 2017

TodayJul 2, 2026

Enrollment to primary: 2.6 yearsPosted 11.6 years ago

Interventions

Somatropindrug

Somatropin will be administered as SC injections at a dose of up to 0.043 mg/kg/day. The dose may be adjusted for a change in body weight of at least (plus \[+\]/minus \[-\]) 2 kilograms (kg) from baseline at the Month 6 study visit or for a change in insulin-growth factor-1 (IGF-1), as per investigator assessment.