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A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults (HypoCCS)

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Lilly

Status

Completed

Conditions

Pituitary Insufficiency
Growth Hormone Deficiency, Adult
Hypopituitarism

Treatments

Drug: Somatropin (rDNA origin)

Study type

Observational

Funder types

Industry

Identifiers

NCT01088399
B9R-MC-GDGA (Other Identifier)
6448

Details and patient eligibility

About

The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. The objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient participants with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The participant enrolled meet the criteria of growth hormone deficiency in adults as per the Humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. The decision to receive somatropin or remain untreated is made by the participant in consultation with their attending physician.

While treatment of adult growth hormone deficient participants with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of participants in the context of the overall disease environment.

Enrollment

10,673 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult growth hormone deficiency as per the local Humatrope label and as judged by the attending physician

Exclusion criteria

  • As per the local Humatrope label and as judged by the attending physician

Trial design

10,673 participants in 2 patient groups

Somatropin replacement treatment
Description:
Adult participants with growth hormone deficiency receiving somatropin replacement treatment.
Treatment:
Drug: Somatropin (rDNA origin)
No treatment
Description:
Adult participants with growth hormone deficiency receiving no somatropin replacement treatment.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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