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NCT Number: NCT04968899

IgIV Plus Prednisone vs High-dose Dexamethasone for ITP

ITP patients with low platelet count and active bleeding symptoms are at risk of life-threatening bleeding and therefore require a treatment with a rapid effect, reliable, and sustained. The combination of intravenous immunoglobulin (IVIg) and prednisone (1 mg/kg per day), is more rapidly and more frequently effective than high dose methylprednisolone to increase the platelet count. This combination is therefore usually given in patients with platelets count < 20 x 109/L and moderate to severe bleeding manifestations. Based on common practice in France and on French ITP guidelines, on average 50 % of patients with ITP and profound thrombocytopenia do actually receive IVIg (mostly during the initial phase of the disease) corresponding to approximately 1,500 ITP patients per year in France.

Whereas IVIg is usually well tolerated, renal insufficiency and congestive heart failure may occur, moreover IVIg are costly and non-easily available with supply difficulties in many countries including France.

High dose dexamethasone (DXM) (ie: 40 mg/d for 4 days) has recently emerged as a promising treatment for ITP. One recent meta-analysis as well as a controlled prospective trial suggest that the initial overall response was higher (> 80 %) and the time to response was shorter with dexamethasone (DXM) 40 mg/d given for 4 days compared to standard prednisone.

The investigators hypothesize that DXM could be a reasonable non-inferior alternative to IVIg, more convenient for patients with less adverse events and economically cost-effective for patients with moderate and severe bleeding manifestations.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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 %)
  • 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.

Treatment and study plan

Neofordex®

Drug

Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21.

Other names: Dexamethasone

Intravenous immunoglobulins

Drug

IVIg (1g/kg D1-D2) plus oral prednisone (1 mg/kg/day x 21 days (3 weeks))

Other names: Tegeline®, Clayrig®,, Gammagard®,, Octagam®,, Privigen®,, Other IgIV patent medicine

Primary outcomes

  1. Time to achieve an initial response (R) within 5 days.

    Time frame: 5 days

Secondary outcomes

  1. Time to achieve an initial complete response (CR) in the two arms

    Time frame: between Day 1 and Day 5

    complete response (CR): 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

  2. Duration of overall response from Day 1 to the end of the study in the two arms.

    Time frame: Day 1 to 6 months

  3. Proportion of early treatment switches across arms

    Time frame: before day 5

  4. Number of new bleeding manifestations between Day 1 and Day 5 in the two arms.

    Time frame: between Day 1 and Day 5

  5. Rates of response (R) and complete response (CR) in the two arms.

    Time frame: at Day 28 and at 6 months

  6. Number of new bleeding manifestations in the two arms.

    Time frame: Between Day 5 and Day 28

  7. Number of adverse events in the two arms.

    Time frame: up to 6 months

  8. Number of responders in patients with positive and negative anti-platelets antibodies in the two arms.

    Time frame: At 6 months

  9. Number of outcome in patients with positive and negative anti-platelets antibodies in the two arms.

    Time frame: At 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Matthieu MAHEVAS, MD,PhD

CONTACT

[email protected]

+33 (1) 49 81 20 76

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Intravenous Immunoglobulin Plus Oral Prednisone or High-dose Dexamethasone, for Adults With Immune Thrombocytopenia (ITP) With Moderate and Severe Bleeding: a Randomized, Multicentre Trial

Acronym: IVIORDEX

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 20, 2021
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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