A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency

Ipsen546 enrolled

Overview

This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom

Study Type

OBSERVATIONAL

Enrollment

546

Conditions

Growth Hormone Disorders

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Growth Hormone Deficiency * Patients treated with NutropinAq® * Patients having completed growth (fused epiphyses) Exclusion Criteria: * Active neoplasia * Pregnancy

Locations (1)

Ipsen Central Contact

Slough, Berkshire, United Kingdom

Outcomes

Primary Outcomes

Incidence of serious adverse events

Time frame: when reported

Secondary Outcomes

Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death

Time frame: when reported

Incidence of intercurrent cardiovascular events

Time frame: when reported

Incidence of fractures

Time frame: when reported

Data from ClinicalTrials.gov

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