Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109733
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2005-05-02
Brief Title:
CoolClick Adolescent Transition Study Study of Saizen in Subjects With Childhood-onset Growth Hormone Deficiency
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Phase IIIb Prospective Multicenter Randomized Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen Recombinant Human Growth Hormone r-hGH Using CoolClick in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase CATS
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH Saizen in subjects with childhood-onset growth hormone deficiency COGHD during the transition phase from childhood to adulthood
Detailed Description:
This is a phase IIIb prospective multicenter randomised open label study to determine the safety and efficacy of two different dose regimens of r-hGH with a dose escalation scheme Screening assessments must be completed 30 days prior to SD1 Study Day 1 Eligible subjects ages 13 to 25 years will be randomised in equal allocation in a 11 ratio to one of two treatment groups 30 subjectsgroup Daily subcutaneous injections will be self-administered or received from a designated individual using coolclick the needle-free growth hormone GH delivery device The study consists of three periods screening up to 30 days prior to Study Day 1 active treatment up to 24 weeks and follow-up 4 week safety evaluation after the last dose of study medication
Each subject will be required to complete a daily treatment diary to assess dosing compliance adverse events and concomitant medications Each subject will receive one treatment diary at SD1 weeks 8 12 and 24 Subjects will be required to record daily diary entries that will capture dosing compliance adverse events and concomitant medications Depending upon treatment allocation and subject tolerability dose titration will be increased as follows
Group A 0005 mgkgday for 30 days then increasing with the Investigators approval to 0010 mgkgday from day 31 to week 24
Group B 0010 mgkgday for 14 days with the opportunity to dose escalate with the Investigators approval on day 15 to 002 mgkgday and day 29 to 003 mgkgday
Scheduled study visits include screening baseline and weeks 8 12 and 24 Dosage adjustments will be based on subject tolerability and telephone assessments from study drug initiation through week 6 Trunk fat will be measured at SD1 weeks 12 and 24 or early termination visit Routine clinical laboratory assessments hematology blood chemistries and urinalysis will be performed pre-treatment -30 to -1 SD1 and post-treatment on week 24 or early termination visit Special laboratory assessments include the central analysis of lipid panel fasting insulin fasting glucose insulin-like growth factor I IGF-I insulin-like growth factor binding protein 3 IGFBP-3 free thyroxine T4 total T4 C-reactive protein CRP Physical exams will be performed at screening weeks 12 and 24 Safety evaluations will occur during scheduled study visits through telephone assessments and by the review of adverse events and concomitant events on the subject treatment diary
Each subject will be required to complete a daily treatment diary to assess dosing compliance adverse events and concomitant medications Each subject will receive one treatment diary at SD1 weeks 8 12 and 24 Subjects will be required to record daily diary entries that will capture dosing compliance adverse events and concomitant medications Depending upon treatment allocation and subject tolerability dose titration will be increased as follows
Group A 0005 mgkgday for 30 days then increasing with the Investigators approval to 0010 mgkgday from day 31 to week 24
Group B 0010 mgkgday for 14 days with the opportunity to dose escalate with the Investigators approval on day 15 to 002 mgkgday and day 29 to 003 mgkgday
Scheduled study visits include screening baseline and weeks 8 12 and 24 Dosage adjustments will be based on subject tolerability and telephone assessments from study drug initiation through week 6 Trunk fat will be measured at SD1 weeks 12 and 24 or early termination visit Routine clinical laboratory assessments hematology blood chemistries and urinalysis will be performed pre-treatment -30 to -1 SD1 and post-treatment on week 24 or early termination visit Special laboratory assessments include the central analysis of lipid panel fasting insulin fasting glucose insulin-like growth factor I IGF-I insulin-like growth factor binding protein 3 IGFBP-3 free thyroxine T4 total T4 C-reactive protein CRP Physical exams will be performed at screening weeks 12 and 24 Safety evaluations will occur during scheduled study visits through telephone assessments and by the review of adverse events and concomitant events on the subject treatment diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None