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Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)

NCT01738360 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-01-06

No results posted yet for this study

Summary

Primary objectives :

* To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE,
* To determine the maximum tolerated dose of ATO.

Secondary objectives :

* Evaluation of the clinical and biological response of the SLE to ATO,
* Time of relapse in case of positive response,
* Determination of the efficacy,
* Pharmacokinetic study of ATO.

Conditions

  • Systemic Lupus

Interventions

DRUG

Arsenic trioxide

The study duration was 30 months (24 months recruitment + 6 months follow-up).Thirteen patients will be successively included in this study at 6 different dose levels of arsenic trioxide (0.075, 0.10, 015, 0.20, 0.25 and 0.30 mg / kg / day). The treatment should be administered by IV infusion over 2 hours of D1 to D4 (conventional hospitalization) and at D8, D11, D15, D18, D22 and D25. The protocol starts at the dose of 0.10 mg / kg / day. The stage at the dose of 0.075mg/kg/day is planned in case of toxicity with the first stage at the dose of 0.10mg/kg/day. The course of study is as follows : * Pre-inclusion between D-35 and D-15 * Ten injections during the first month distributed as follows : conventional hospitalization from D1 to D4 (one injection per day) and daily hospitalization day for injections at D8, D11, D15, D18, D22 and D25. * A telephone contact between D32 and D34 * A consultation at D40 then monthly consultation at D60, D90, D120, D150 and D180

Sponsors & Collaborators

  • Medsenic Company

    collaborator UNKNOWN

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Mohamed HAMIDOU, Profesor · Nantes University Hospital

  • Zahir AMOURA, Profesor · AP-HP - La Pitié-Salpétrière

  • Jean SIBILIA, Profesor · CHRU de Strasbourg

  • Jean-François VIALLARD, Profesor · University Hospital, Bordeaux

  • Nicolas SCHLEINITZ, Profesor · CHU de Marseille

  • Eric HACHULLA, Profesor · CHRU de Lille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-10-31
Completion
2015-10-31

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 NCT01738360 on ClinicalTrials.gov