Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 4:53 PM
Study NCT ID:
NCT03365869
Status:
UNKNOWN
Last Update Posted:
2017-12-07
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis
Sponsor:
Peking University People's Hospital
Organization:
Study Overview
Official Title:
A Phase Ⅱ Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
NOT_YET_RECRUITING
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 purpose of the study is to examine the safety and effectiveness of sirolimus treatment for people with systemic sclerosis.
The investigators perform a multi-centre, double-blind pilot trial with sirolimus in SSc.The investigators evaluate the effectiveness and safeness of sirolimus for Systemic Sclerosis by randomized controlled study (sirolimus 2mg/d (N = 36) versus placebo group (N = 36)).
The investigators perform a multi-centre, double-blind pilot trial with sirolimus in SSc.The investigators evaluate the effectiveness and safeness of sirolimus for Systemic Sclerosis by randomized controlled study (sirolimus 2mg/d (N = 36) versus placebo group (N = 36)).
Detailed Description:
Each SSc patients (n=72) received sirolimus or placebo (active group: placebo group =1:1, 2mg/day， oral administration, (SIR 2mg, po., Qd) .
The end points were the changement of modified RSS and the adverse events or severe adverse events onset.
The end points were the changement of modified RSS and the adverse events or severe adverse events onset.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: