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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 With High Platelet Desialylation Level

Information source: Shandong University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Focus of Study

Intervention: Oseltamivir (Drug); Dexamethasone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Shandong University

Overall contact:
Ming Hou, Docter, Email: houming@medmail.com.cn

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 5 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.

Clinical Details

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 With High Platelet Desialylation Level

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Primary outcome: Evaluation of platelet response

Detailed description: The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 newly diagnosed ITP adult patients with high platelet desialylation level from 6 medical centers in China. One part of the participants are randomly selected to receive oseltamivirphosphate (oral administration at a dose of 75 mg twice for 5 consecutive days), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4 days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count, bleeding 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 with high platelet desialylation level.

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- newly diagnosed ITP patients with high platelet desialylation level 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

Locations and Contacts

Ming Hou, Docter, Email: houming@medmail.com.cn

Qilu hospital, Shandong University, Jinan, Shandong 250012, China; Recruiting
Ming Hou, Email: houming@medmail.com.cn
Ming Hou, Principal Investigator
Additional Information

Starting date: October 2013
Last updated: May 26, 2014

Page last updated: August 23, 2015

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