NCT01080755

Brief Summary

This is a multicentric, longitudinal, observational study with the prospective follow-up of Adult subjects with Growth Hormone Deficiency (AGHD) being treated with Saizen, every six months in the first year and then annually. At the request of health authorities, the sponsor has arranged for the follow-up of prescriptions and treated subjects within the scope of this indication.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

8.8 years

First QC Date

March 3, 2010

Last Update Submit

March 10, 2014

Conditions

Adult Growth Hormone Deficiency

Keywords

Adult Growth Hormone DeficiencyPituitarySaizenSomatropinGrowth Hormone

Outcome Measures

Primary Outcomes (1)

  • Longitudinal follow up of subjects treated with Saizen

    Demographic data and medical history (date of birth, sex, diagnosis of the hypophyseal pathology and the GH deficit, other hormonal abnormalities, etc.); Clinical and biological data (size, weight, vital signs, body composition, cardiac function, insulin growth factor -1 (IGF1), blood lipids, etc.); Data on the terms and conditions of prescription of the GH (start date, dose, injection cycle, modifications or discontinuation of treatment); Related treatments and Information of the side effects and problems linked to the injection.

    Data to be collected from the start of the follow-up period up to 5 years (every six months in the first year and then annually)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult subjects treated with Saizen, irrespective of whether it concerns a first time prescription or a renewal were enrolled in the study.

You may qualify if:

  • Adult subjects treated with Saizen, irrespective of whether it concerns a first time prescription or a renewal were enrolled in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Dwarfism, PituitaryPituitary Diseases

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 4, 2010

Study Start

December 1, 2003

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 11, 2014

Record last verified: 2014-03