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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01965626
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: Oseltamivir Drug: Dexamethasone Phase 2

Detailed Description:

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 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).

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Open-label Study of Oseltamivir Combined With High-dose Dexamethasone Versus High-dose Dexamethasone in the Management of Immune Thrombocytopenia
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2019


Arm Intervention/treatment
Active Comparator: Oseltamivir Combining HD-DXM

Oseltamivir 75 mg twice per day, 10consecutive days

HD-DXM (orally at 40 mg daily for 4d )

Drug: Oseltamivir
Oseltamivir 75 mg twice per day, 10 consecutive days

Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d)

Active Comparator: HD-DXM
HD-DXM (orally at 40 mg daily for 4d )
Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d)




Primary Outcome Measures :
  1. initial response and sustained response (SR) [ Time Frame: Initial responses were assessed by day 14. Response lasting for at least 6 consecutive months without additional ITP-specific intervention was regarded as 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01965626


Locations
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China, Shandong
Qilu hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University

Publications of Results:
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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT01965626    
Other Study ID Numbers: ITP-Oseltamivir
ITP-Oseltamivirphosphate ( Registry Identifier: ITP-Oseltamivirphosphate )
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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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 Ming Hou, Shandong University:
Oseltamivir
Dexamethasone
ITP
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Oseltamivir
Dexamethasone
Dexamethasone acetate
BB 1101
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
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents