Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02627417
Status:
UNKNOWN
Last Update Posted:
2017-07-26
First Post:
2015-11-03
Brief Title:
Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia
Status:
UNKNOWN
Status Verified Date:
2017-07
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:
DAPS-ITP
Brief Summary:
Due to its expected efficacy based on the retrospective data available in ITP its relatively good safety profile and its very low cost dapsone could be a good steroid-sparing second-line option for adults with ITP
This study is a phase III prospective multicenter randomized open trial comparing two treatment strategies
Arm A experimental arm prednisone at 1 mgkg for 3 weeks dapsone at 100 mg per day up to week 52 if an initial response is achieved
Arm B control arm prednisone alone at 1 mgkg for 3 weeks followed by monitoring and standard of care The aim of the study is to demonstrate the efficacy of dapsone based on the overall response rate including response and complete response as a second-line treatment for adults with newly-diagnosed persistent or chronic modified by amendment 08112016 ITP not achieving a durable response with corticosteroids The primary endpoint will be the overall response-rate response or complete response according to standard definitions in both arms at week 52 1 year
The secondary endpoints are the following
To assess the safety of dapsone over the study period and especially the incidence of cutaneous reactions
To analyze the overall response rate platelet count 30 x 109L with at least a doubling of the pre-treatment count in the absence of any other ITP treatment in both treatment arms at week 24
To compare the rate of complete response and failure in both arms at 24 and 52 weeks
To compare time to treatment failure TTF in both arms
To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients ancillary study
This study is a phase III prospective multicenter randomized open trial comparing two treatment strategies
Arm A experimental arm prednisone at 1 mgkg for 3 weeks dapsone at 100 mg per day up to week 52 if an initial response is achieved
Arm B control arm prednisone alone at 1 mgkg for 3 weeks followed by monitoring and standard of care The aim of the study is to demonstrate the efficacy of dapsone based on the overall response rate including response and complete response as a second-line treatment for adults with newly-diagnosed persistent or chronic modified by amendment 08112016 ITP not achieving a durable response with corticosteroids The primary endpoint will be the overall response-rate response or complete response according to standard definitions in both arms at week 52 1 year
The secondary endpoints are the following
To assess the safety of dapsone over the study period and especially the incidence of cutaneous reactions
To analyze the overall response rate platelet count 30 x 109L with at least a doubling of the pre-treatment count in the absence of any other ITP treatment in both treatment arms at week 24
To compare the rate of complete response and failure in both arms at 24 and 52 weeks
To compare time to treatment failure TTF in both arms
To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients ancillary study
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