Immune Thrombocytopenia (ITP)Phase 3IVIORDEXNCT04968899
IgIV Plus Prednisone vs High-dose Dexamethasone for ITP
A Phase 3 study testing Neofordex® and Intravenous immunoglobulins in people with Immune Thrombocytopenia (ITP), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- Neofordex® and Intravenous immunoglobulins
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2022to 9 Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, 94010
Matthieu MAHEVAS, PHD, +33149812076, matthieu.mahevas@aphp.fr
About this study
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
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.
Read more
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.
- Conditions
- Immune Thrombocytopenia (ITP)
- Being tested
- Neofordex®, Intravenous immunoglobulins
- Keywords
- Immune thrombocytopenia (ITP), Dexamethasone, IntraVenous Immunoglobulin, Prednisone
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neofordex®Drug
Also called Dexamethasone
Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21.
Intravenous immunoglobulinsDrug
Also called Tegeline®, Clayrig®,, Gammagard®,, Octagam®,
IVIg (1g/kg D1-D2) plus oral prednisone (1 mg/kg/day x 21 days (3 weeks))
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21 Receives: Drug: Neofordex® |
| Control | Active comparator | IVIg (1g/kg D1-D2) plus prednisone (1 mg/kg/day x 21 days (3 weeks)) Receives: Drug: Intravenous immunoglobulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve an initial response (R) within 5 days.
Measured: 5 days
Secondary outcomes (9)
Time to achieve an initial complete response (CR) in the two arms
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
Measured: between Day 1 and Day 5
Duration of overall response from Day 1 to the end of the study in the two arms.
Measured: Day 1 to 6 months
Proportion of early treatment switches across arms
Measured: before day 5
Number of new bleeding manifestations between Day 1 and Day 5 in the two arms.
Measured: between Day 1 and Day 5
Rates of response (R) and complete response (CR) in the two arms.
Measured: at Day 28 and at 6 months
Number of new bleeding manifestations in the two arms.
Measured: Between Day 5 and Day 28
Number of adverse events in the two arms.
Measured: up to 6 months
Number of responders in patients with positive and negative anti-platelets antibodies in the two arms.
Measured: At 6 months
Number of outcome in patients with positive and negative anti-platelets antibodies in the two arms.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start7 Apr 2022
- Primary completion9 Apr 2025 (estimated)
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968899
- Sponsor's protocol ID
- APHP200017
- Other IDs
- 2021-000292-37
- Acronym
- IVIORDEX
- Status last verified
- Sep 2023
- First submitted
- 9 Jul 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04968899
- Acronym / sponsor ID
- IVIORDEX / APHP200017
- Conditions
- Immune Thrombocytopenia (ITP)
- Keywords
- Immune thrombocytopenia (ITP), Dexamethasone, IntraVenous Immunoglobulin, Prednisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 9 Apr 2025 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Neofordex®Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21 |
| Control | Active comparator | Drug: Intravenous immunoglobulinsIVIg (1g/kg D1-D2) plus prednisone (1 mg/kg/day x 21 days (3 weeks)) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neofordex®Also: DexamethasoneOral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21. | Drug | Experimental group |
| Intravenous immunoglobulinsAlso: Tegeline®, Clayrig®,, Gammagard®,, Octagam®,IVIg (1g/kg D1-D2) plus oral prednisone (1 mg/kg/day x 21 days (3 weeks)) | Drug | Control |
Primary outcome
Time to achieve an initial response (R) within 5 days.
Time frame: 5 days
9 secondary outcomes
Time to achieve an initial complete response (CR) in the two arms
Time frame: between Day 1 and Day 5
Duration of overall response from Day 1 to the end of the study in the two arms.
Time frame: Day 1 to 6 months
Proportion of early treatment switches across arms
Time frame: before day 5
Number of new bleeding manifestations between Day 1 and Day 5 in the two arms.
Time frame: between Day 1 and Day 5
Rates of response (R) and complete response (CR) in the two arms.
Time frame: at Day 28 and at 6 months
Number of new bleeding manifestations in the two arms.
Time frame: Between Day 5 and Day 28
Number of adverse events in the two arms.
Time frame: up to 6 months
Number of responders in patients with positive and negative anti-platelets antibodies in the two arms.
Time frame: At 6 months
Number of outcome in patients with positive and negative anti-platelets antibodies in the two arms.
Time frame: At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Related trials for Immune Thrombocytopenia (ITP)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neofordex® and Intravenous immunoglobulins in people with Immune Thrombocytopenia (ITP), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu MAHEVAS, MD,PhD (+33 (1) 49 81 20 76, matthieu.mahevas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve an initial response (R) within 5 days. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.