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

NCT01965626 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-08-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Oseltamivir

Oseltamivir 75 mg twice per day, 10 consecutive days

DRUG

Dexamethasone

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

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2018-05-31
Completion
2019-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01965626 on ClinicalTrials.gov