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).
- 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
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
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
Name Time Method 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
Name Time Method 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
Scroll for more (21 remaining)Assistance Publique Hopitaux De Paris🇫🇷Paris, FranceNicolas NOELSite contact+33145212783nicolas.noel@aphp.frDelphine GOBERTSite contact+33171970764delphine.gobert@aphp.frJehane FADLALLAHSite contact+33142499690jehane.fadlallah@aphp.frAntoine DOSSIERSite contact+33140257005antoine.dossier@aphp.frEdouard FLAMARIONSite contact+33156095341edouard.flamarion@aphp.frMatthieu MAHEVASSite contact+33149812076matthieu.mahevas@aphp.frNathalie COSTEDOAT CHALUMEAUSite contact+33687508123nathalie.costedoat@aphp.fr