NCT01082354|Completed

A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)

SEPAGE

Non Interventional Study on the Follow-up, by Specialists, of Short Children Born Small for Gestational Age and Treated With SAIZEN®- SEPAGE Study

Merck KGaA, Darmstadt, Germany ClinicalTrials.gov

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1 other identifier

IMP28018

Study Type

observational

Target

150

Locations

1 country

Sites

Timeline

RegisteredMar 2010

StartedMar 2009

CompletionDec 2015

Brief Summary

This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.

Trial Health

On Track

Trial Health Score

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

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach

1 country

40 active sites

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

6.8 years study duration

Study Start

First participant enrolled

March 1, 2009

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

March 5, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

6.8 years

First QC Date

March 5, 2010

Last Update Submit

February 11, 2016

Conditions

Infant, Small for Gestational Age

Keywords

Infant, Low birth weightInfant, Low birth heightInfant, Small for Gestational Age

Outcome Measures

Primary Outcomes (4)

Auxological characteristics (height and weight, head circumference, growth curve used, bone age) and Clinical examination (cardiac frequency, systolic blood pressure, diastolic blood pressure, Tanner pubertal stage)
Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Saizen prescription and compliance to treatment
Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Temporary discontinuation of treatment with Saizen if > 1 week (number, duration, person responsible for the discontinuation, reason, dose upon resumption of treatment) and final discontinuation of treatment with Saizen (date and reason)
Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Biochemical and endocrinological parameters
* Tolerance * Concomitant treatments
Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment

Interventions

recombinant somatropinDRUG

as per standard practice

Also known as: Saizen

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

48 hospital pediatric and endocrinology centers or in mixed private and hospital practice will enroll 150 children

You may qualify if:

Subjects whose parents have given their written consent for participation in this study

You may not qualify if:

Contra-indication in the treatment with Saizen

Contact the study team to confirm eligibility.