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Trial record 31 of 66 for:    Recruiting Studies | Immune Thrombocytopenia

IgIV Plus Prednisone vs High-dose Dexamethasone for ITP (IVIORDEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04968899
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : April 21, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia (ITP) Drug: Neofordex® Drug: Intravenous immunoglobulins Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 7, 2022
Estimated Primary Completion Date : April 9, 2025
Estimated Study Completion Date : October 9, 2026


Arm Intervention/treatment
Experimental: Experimental group
Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21
Drug: Neofordex®
Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21.
Other Name: Dexamethasone

Active Comparator: Control
IVIg (1g/kg D1-D2) plus prednisone (1 mg/kg/day x 21 days (3 weeks))
Drug: Intravenous immunoglobulins
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 Outcome Measures :
  1. Time to achieve an initial response (R) within 5 days. [ Time Frame: 5 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968899


Contacts
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Contact: Matthieu MAHEVAS, MD,PhD +33 (1) 49 81 20 76 matthieu.mahevas@aphp.fr

Locations
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France
Henri Mondor Hospital Recruiting
Créteil, France, 94010
Contact: Matthieu MAHEVAS, PHD    +33149812076    matthieu.mahevas@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04968899    
Other Study ID Numbers: APHP200017
2021-000292-37 ( EudraCT Number )
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Immune thrombocytopenia (ITP)
Dexamethasone
IntraVenous Immunoglobulin
Prednisone
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Dexamethasone
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal