Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Novo Nordisk A/S86 enrolled

Overview

This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency

Interventions

somatropinDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 67 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who completed GHLiquid-1519. * If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded. * Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies. Exclusion Criteria: * Subject with a history of acromegaly. * Subject with diabetes mellitus. * Subject suffering from malignancy. * Several medical conditions

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)

Time frame: at the end of treatment

GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio)

Time frame: at the end of treatment

Secondary Outcomes

Adverse events

FPG, insulin, and HbA1C

Clinical laboratory tests

Data from ClinicalTrials.gov

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