A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP

Study Overview
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Brief Summary
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Oseltamivirphosphate is hydrolysed to its active metabolite-the free carboxylate of oseltamivir. Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent platelet destruction in liver.The project was undertaking by Qilu Hospital of Shandong University and other 4 well-known hospitals in China. In order to report the efficacy and safety of oseltamivirphosphate combined with high-dose dexamethasone for the treatment of immune thrombocytopenia (ITP) with high platelet desialylation level, compared to high-dose dexamethasone therapy.

Detailed Description
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The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 50 newly diagnosed ITP adult patients with high platelet desialylation level from 5 medical centers in China. One part of the participants are randomly selected to receiver HD-DXM (orally at 40 mg daily for 4d) combined with oseltamivir (orally at 75 mg twice for 10d), the others are selected to receive HD-DXM (orally at 40 mg daily for 4d ) alone. If platelet counts remained <30×109/L or there were bleeding symptoms by day 10, another 4-day course of HD-DXM was given (days 10-14).For the combination arm, patients with an initial response relapsed during the follow-up period, oseltamivir retreatment could be given for another 10 days at the discretion of the physician's advice and patients' will. Platelet count, bleeding , platelet desialylation level and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of oseltamivirphosphate combining with high-dose dexamethasone therapy compared to high-dose dexamethasone for the treatment of adults with newly diagnosed ITP .

Official Title
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A Multicenter Randomized Open-label Study of Oseltamivir Combined With High-dose Dexamethasone Versus High-dose Dexamethasone in the Management of Immune Thrombocytopenia

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Drug: Oseltamivir
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia Exclusion Criteria: pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oseltamivir Combining HD-DXM<br>Oseltamivir 75 mg twice per day, 10consecutive days HD-DXM (orally at 40 mg daily for 4d ) | Drug: Oseltamivir<br>* Oseltamivir 75 mg twice per day, 10 consecutive days<br>Drug: Dexamethasone<br>* HD-DXM (orally at 40 mg daily for 4d)<br>|
| Active Comparator: HD-DXM<br>HD-DXM (orally at 40 mg daily for 4d ) | Drug: Dexamethasone<br>* HD-DXM (orally at 40 mg daily for 4d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial response and sustained response (SR) | CR: platelet count ≥ 100 × 109/L and absence of bleeding; R: platelet count ≥ 30 × 109/L but < 100 × 109/L and a doubling from baseline and absence of bleeding. | Initial responses were assessed by day 14. Response lasting for at least 6 consecutive months without additional ITP-specific intervention was regarded as SR. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oseltamivir, Dexamethasone, ITP