Ignite Creation Date:
2024-05-06 @ 1:03 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03923140
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-04-14
Brief Title:
A Clinical Study of Tranilast in the Treatment of Cryopyrin-Associated Periodic Syndrome CAPS
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Efficacy and Safety of Tranilast in Patients With Cryopyrin-Associated Periodic Syndrome CAPS A Single-Arm Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
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:
This is a prospective cohort study to observe the efficacy and safety of tranilast in CAPS patients The investigators would analyze the changes in Auto-Inflammatory Diseases Activity Index AIDAI before and after treatment as well as changes in inflammatory markers patients and physicians global assessment of disease activity to determine the efficacy and safety of tranilast
Detailed Description:
Seventy-one patients with CAPS will be recruited After signing the informed consent they will be administrated with tranilast For juvenile patients 5mgkgd with a maximum dose of 03g per day For adult patients the dose is 01g each time three times a day These patients will be followed up for 6 months AIDAI is recorded by patients or their parents one month before the start of treatment and at the 1st 3rd and 6th month after the treatment Inflammatory markers and patients and physicians global assessment of disease activity will be assessed during the 1st 3rd and 6th month follow-up Side effects will be monitored and recorded as well Experimental data before and after the administration of tranilast will be analyzed and be statistically processed to figure out whether tranilast is effective and safe for CAPS patients
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?:
False
Is an FDA AA801 Violation?:
None