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Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia

NCT02627417 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2017-07-26

No results posted yet for this study

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 mg/kg 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 mg/kg 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 08/11/2016) 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 109/L 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)

Conditions

  • Adult Immune Thrombocytopenia (ITP)
  • Dapsone

Interventions

DRUG

Dapsone (Disulone®)

Experimental group will receive dapsone at a fixed dose of 100 mg per day for a total of 12 months unless they fail to respond to the treatment.

DRUG

Prednisone (Cortancyl®) alone followed by monitoring and "standard of care"

Patients randomized in the control arm will be treated only prednisone at a daily dose of 1 mg per kg for 2 weeks and then tapered and stopped over a week for a total of 3 consecutive weeks. After this 3 weeks period, patients from arm B will be left without treatment and monitored.

DRUG

Prednisone (Cortancyl®)

Experimental group will receive prednisone at a daily dose of 1 mg per kg for 2 weeks and then tapered and stopped over a week for a total of 3 consecutive weeks.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • MARC MICHEL, Prof. M.D · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627417 on ClinicalTrials.gov