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

Sponsor

Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT01965626

Collaborator

(none)

Enrollment

Location

Arms

38.9

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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 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 .

Study Design

Study Type:

Interventional

Actual Enrollment :

96 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 :

Feb 1, 2016

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

initial response and sustained response (SR) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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