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Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study

NCT01237340 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2013-08-07

Study results available
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Summary

To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).

Conditions

  • Growth Hormone Deficiency (GHD)

Interventions

DRUG

Saizen®

Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · Merck Serono S.A., Geneva

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01237340 on ClinicalTrials.gov