Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294164
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2006-02-16
Brief Title:
Safety and Efficacy Trial of Serostim in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome HARS
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
Phase 23 Multicenter Double-blind Randomized Placebo-controlled Parallel-group Dose-finding Safety and Efficacy Trial of Subcutaneously Administered Serostim Mammalian Cell-derived Recombinant Human Growth Hormone r-hGH in the Treatment of Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome HARS
Status:
COMPLETED
Status Verified Date:
2014-03
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:
This study is a Phase 23 multicenter double-blind randomized parallel-group placebo-controlled dose-finding trial of Serostim mammalian cell-derived recombinant human growth hormone r-hGH versus placebo in subjects with human immunodeficiency virus-associated adipose tissue redistribution syndrome HARS
The primary study objective is to determine whether Serostim treatment reduces adipose tissue maldistribution more effectively than placebo The primary co-endpoints are derived from measures of visceral adipose tissue assessed by computerized tomography CT and the ratio of trunk and limb fat assessed by dual-energy X-Ray absorptiometry DXA scans Anthropometric measures physical exams quality of life assessments serial photographs and various laboratory measures will be used to address secondary objectives These secondary objectives relate to the impact of Serostim on Physician and subject assessments of change in body shape health-related quality of life attitude towards medication compliance metabolic markers fat redistribution and safety
On Day 1 eligible subjects will be randomized in a 111 ratio to receive daily Serostim Serostim and placebo given on alternate days or daily placebo Serostim doses will be based on body weight with a maximum dose of 4 milligram mg
Therapy will continue for 12 weeks Treatment will then be altered and the new treatment will be continued through Week 24 Interim Study Visits will be required at Weeks 2 and 4 Treatment Period 1 and at Weeks 14 and 16 Treatment Period 2 Subjects will be offered to be enrolled into a maintenance Protocol Study 23056 at Week 24
The primary study objective is to determine whether Serostim treatment reduces adipose tissue maldistribution more effectively than placebo The primary co-endpoints are derived from measures of visceral adipose tissue assessed by computerized tomography CT and the ratio of trunk and limb fat assessed by dual-energy X-Ray absorptiometry DXA scans Anthropometric measures physical exams quality of life assessments serial photographs and various laboratory measures will be used to address secondary objectives These secondary objectives relate to the impact of Serostim on Physician and subject assessments of change in body shape health-related quality of life attitude towards medication compliance metabolic markers fat redistribution and safety
On Day 1 eligible subjects will be randomized in a 111 ratio to receive daily Serostim Serostim and placebo given on alternate days or daily placebo Serostim doses will be based on body weight with a maximum dose of 4 milligram mg
Therapy will continue for 12 weeks Treatment will then be altered and the new treatment will be continued through Week 24 Interim Study Visits will be required at Weeks 2 and 4 Treatment Period 1 and at Weeks 14 and 16 Treatment Period 2 Subjects will be offered to be enrolled into a maintenance Protocol Study 23056 at Week 24
Detailed Description:
None
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