Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016445
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2001-05-06
Brief Title:
Phase II Study of Growth Hormone in Children With Cystic Fibrosis
Sponsor:
University of Utah
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-09
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:
OBJECTIVES I Determine the effect of growth hormone on height height velocity body weight and lean body mass in patients with cystic fibrosis
II Determine the effect of growth hormone on pulmonary function in these patients
III Determine the impact of this drug on the quality of life in these patients
IV Determine if the clinical response from this drug is sustained in these patients
II Determine the effect of growth hormone on pulmonary function in these patients
III Determine the impact of this drug on the quality of life in these patients
IV Determine if the clinical response from this drug is sustained in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive growth hormone subcutaneously SC daily for 1 year during the first year only
Arm II Patients receive growth hormone SC daily for 1 year during the second year only
Quality of life is assessed at baseline and then every 6 months for 2 years
Arm I Patients receive growth hormone subcutaneously SC daily for 1 year during the first year only
Arm II Patients receive growth hormone SC daily for 1 year during the second year only
Quality of life is assessed at baseline and then every 6 months for 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GENENTECH-UUSOM-IRB-7797-00 | None | None | None |
| UUSOM-IRB-7797-00 | None | None | None |