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
|