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Intravenous Immunoglobulin plus oral prednisone or high-dose dexamethasone, for adults with immune thrombocytopenia (ITP) with moderate and severe bleeding: a randomized, multicentre trial (IVIORDEX).

Phase 3
Recruiting
Conditions
Adult patients with immune thrombocytopenia (ITP) with mild to severe bleeding manifestations
Registration Number
2024-516403-16-00
Lead Sponsor
Assistance Publique Hopitaux De Paris
Brief Summary

To demonstrate the non-inferiority in term of short-term response of oral dexamethasone given at 40 mg on days 1 to 4 compared to IVIg given at 1g/kg on days 1 and 2 in combination with prednisone (1 mg/kg per day for 3 weeks) in adult patients with immune thrombocytopenia (ITP) with mild to severe bleeding manifestations.

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing, recruiting
Sex
Not specified
Target Recruitment
272
Inclusion Criteria

Age ≥ 18 years ≤ 80 years

Diagnosis of ITP whatever the duration of the disease (newly diagnosed or relapsed) according to the standard definition

Platelet count ≤ 20 x 109/L

Any cutaneous and/or any mucosal bleeding manifestations

Affiliated to a social security regime

Written consent from patient

Exclusion Criteria

Symptomatic COVID-19 disease

Ongoing viral infection (uncontrolled HIV, Viral hepatitis, herpes, varicella, zona)

Uncontrolled diabetes (Acido-cetosis)

Psychotic state not yet controlled by treatment

Inability or refusal to understand or refusal to sign the informed consent from study participation

Persons deprived of their liberty by judicial or administrative decision

Persons under legal protection (guardianship, curatorship)

Pregnant or breastfeeding woman or ineffective contraception

Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants

Life-threatening bleeding defined as Intracranial hemorrhage and/or active organ bleeding (GI tract, urinary tract or menorrhagia with at least a 2 g/dl decrease of hemoglobin value from baseline).

Ongoing anticoagulation treatment (Therapeutic Low molecular weight heparins (LMWHs), direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs))

Previous non-response to IVIg or DEX

Treatment with prednisone (1 mg/kg per day) for more than 3 days

Any contraindications to the prescribed Ig IV or prednisone patent medicine and to Neofordex®

Ongoing severe infection

Severe Renal insufficiency (DFG < 45 ml.min.1.73m2)

Severe Cardiac insufficiency (FEVG < 30 %)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time (in days) to achieve an initial response (R) within 5 days. - Initial response (R) will be defined according to international guidelines (5) as a platelet count ≥ 30x109/L with at least a doubling of the baseline value in the absence of new bleeding and absence of the use of any other ITP directed therapies (other than the one of the treatment arm)

Time (in days) to achieve an initial response (R) within 5 days. - Initial response (R) will be defined according to international guidelines (5) as a platelet count ≥ 30x109/L with at least a doubling of the baseline value in the absence of new bleeding and absence of the use of any other ITP directed therapies (other than the one of the treatment arm)

Secondary Outcome Measures
NameTimeMethod
Time (in days) to achieve an initial complete response (CR) in both arms (defined by a platelet count > 100 x 109/L in the absence use of any other ITP directed therapies between Day 1 and Day 5) in the two arms.

Time (in days) to achieve an initial complete response (CR) in both arms (defined by a platelet count > 100 x 109/L in the absence use of any other ITP directed therapies between Day 1 and Day 5) in the two arms.

Duration in time (in days) of overall response from Day 1 to the end of the study (6 months) in the two arms.

Duration in time (in days) of overall response from Day 1 to the end of the study (6 months) in the two arms.

Proportion of early (before day 5) treatment switches across arms

Proportion of early (before day 5) treatment switches across arms

Number of new bleeding manifestations between Day 1 and Day 5 in two arms. Bleeding manifestations will be assessed the score reported by Khellaf et al. without taking into account the age of the patient.

Number of new bleeding manifestations between Day 1 and Day 5 in two arms. Bleeding manifestations will be assessed the score reported by Khellaf et al. without taking into account the age of the patient.

Rates of response (R) and complete response (CR) at 28 days, and 6 months in the two arms.

Rates of response (R) and complete response (CR) at 28 days, and 6 months in the two arms.

Number of bleeding manifestations between Day 5 and Day 28 in the two arms.

Number of bleeding manifestations between Day 5 and Day 28 in the two arms.

Number of days of hospitalization between Day 1 and Day 28 in the two arms.

Number of days of hospitalization between Day 1 and Day 28 in the two arms.

Number of adverse events in the two arms.

Number of adverse events in the two arms.

Incremental (decremental) cost effectiveness ratio expressed in cost per responder at 6 months

Incremental (decremental) cost effectiveness ratio expressed in cost per responder at 6 months

Comparison of the number of responders, and outcome at 6 months in patients with positive and negative anti-platelets antibodies in the two arms.

Comparison of the number of responders, and outcome at 6 months in patients with positive and negative anti-platelets antibodies in the two arms.

Trial Locations

Locations (31)

Assistance Publique Hopitaux De Paris

🇫🇷

Paris, France

Centre Hospitalier Regional De Marseille

🇫🇷

Marseille, France

CHRU De Nancy

🇫🇷

Vandoeuvre Les Nancy, France

Centre Hospitalier Universitaire De Bordeaux

🇫🇷

Pessac, France

Centre Hospitalier Universitaire D'Angers

🇫🇷

Angers, France

Centre Hospitalier Universitaire De Toulouse

🇫🇷

Toulouse, France

Centre Hospitalier Universitaire De Caen Normandie

🇫🇷

Caen Cedex 9, France

Hopital Saint Joseph

🇫🇷

Marseille, France

Centre Hospitalier Regional Et Universitaire De Brest

🇫🇷

Brest, France

Hospices Civils De Lyon

🇫🇷

Lyon Cedex 04, France

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Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Nicolas NOEL
Site contact
+33145212783
nicolas.noel@aphp.fr
Delphine GOBERT
Site contact
+33171970764
delphine.gobert@aphp.fr
Jehane FADLALLAH
Site contact
+33142499690
jehane.fadlallah@aphp.fr
Antoine DOSSIER
Site contact
+33140257005
antoine.dossier@aphp.fr
Edouard FLAMARION
Site contact
+33156095341
edouard.flamarion@aphp.fr
Matthieu MAHEVAS
Site contact
+33149812076
matthieu.mahevas@aphp.fr
Nathalie COSTEDOAT CHALUMEAU
Site contact
+33687508123
nathalie.costedoat@aphp.fr

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