MedTrace Logo

Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients

NCT01822340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-02-19

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.

Conditions

  • Adult Growth Hormone Deficiency

Interventions

DRUG

HM10560A

Once weekly HM10560A

DRUG

Genotropin

Once daily Genotropin

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-06-30
Completion
2016-02-29

Countries

  • Hungary

Study Locations

More Related Trials

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 NCT01822340 on ClinicalTrials.gov