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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088399
First received: February 25, 2010
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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 patients with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The patients 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 patient in consultation with their attending physician.

While treatment of adult growth hormone deficient patients 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 patients in the context of the overall disease environment.


Condition Intervention
Hypopituitarism
Pituitary Insufficiency
Growth Hormone Deficiency, Adult
Drug: Somatropin (rDNA origin)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Global Hypopituitary Control and Complications Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Clinically significant adverse events during somatropin replacement therapy. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate long-term benefits of somatropin replacement therapy with regard to cardiovascular risk factors. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
  • Evaluate long-term benefits of somatropin replacement therapy with regard to fracture incidence. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
  • Evaluate long-term benefits of somatropin replacement therapy with regard to quality of life as assessed by a disease-specific module of the Questions of Life Satisfaction (QLS-H). [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA Addendum - implemented in Germany only. Germany: DNA sample is kept, if patient consented to German DNA Addendum


Estimated Enrollment: 8000
Study Start Date: September 2002
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Somatropin replacement treatment
Adult patients with growth hormone deficiency receiving somatropin replacement treatment.
Drug: Somatropin (rDNA origin)
Dose, frequency and duration are at discretion of attending physician, and determined on an individual patient basis.
Other Names:
  • Humatrope
  • LY137998
No treatment
Adult patients with growth hormone deficiency receiving no somatropin replacement treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinics, private practices

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088399

Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088399     History of Changes
Other Study ID Numbers: 6448, B9R-MC-GDGA
Study First Received: February 25, 2010
Last Updated: February 26, 2013
Health Authority: Austria: Ethikkommission
Belgium: Institutional Review Board
Canada: Ethics Review Committee
Czech Republic: Ethics Committee
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
Italy: Ethics Committee
Japan: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare
Netherlands: Independent Ethics Committee
Spain: Ministry of Health
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism, Pituitary
Hypopituitarism
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014