CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 78 enrolled
Drug / intervention
Saizen® solution for injection (referred as Saizen®)drug
Likely dose
Not stated in 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/NCT01806298
NCT01806298Phase 4Completed
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Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)

Merck KGaA, Darmstadt, Germany·interventional·Posted Mar 7, 2013·Updated Dec 2, 2017

In Brief

A Phase 4 clinical trial evaluating Saizen® solution for injection (referred as Saizen®) for Adult Growth Hormone Deficiency. Completed, enrolled 78 participants across 19 sites in 4 countries.

Detailed Summary

This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency (AGHD), who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD which was stopped at least 1 month prior to Screening and have no contraindication to the use of GH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Growth Hormone Deficiency
CountriesAustralia, Germany, Sweden, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2013
Enrollment StartJun 1, 2013
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.3 years ago

Interventions

Saizen® solution for injection (referred as Saizen®)drug

Saizen® solution for injection will be administered subcutaneously daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.