NCT01965626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

October 15, 2013

Last Update Submit

August 22, 2020

Conditions

Thrombocytopenia

Keywords

OseltamivirDexamethasoneITP

Outcome Measures

Primary Outcomes (1)

  • initial response and sustained response (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.

    Initial responses were assessed by day 14. Response lasting for at least 6 consecutive months without additional ITP-specific intervention was regarded as SR.

Study Arms (2)

Oseltamivir Combining HD-DXM

ACTIVE COMPARATOR

Oseltamivir 75 mg twice per day, 10consecutive days HD-DXM (orally at 40 mg daily for 4d )

Drug: OseltamivirDrug: Dexamethasone

HD-DXM

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

OseltamivirDRUG

Oseltamivir 75 mg twice per day, 10 consecutive days

Oseltamivir Combining HD-DXM
DexamethasoneDRUG

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

HD-DXMOseltamivir Combining HD-DXM

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (3)

  • Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

    PMID: 19846889RESULT

  • Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

    PMID: 19005182RESULT

  • Sun L, Wang J, Shao L, Yuan C, Zhao H, Li D, Wang Z, Han P, Yu Y, Xu M, Zhao H, Qiu J, Zhou H, Liu X, Hou Y, Peng J, Hou M. Dexamethasone plus oseltamivir versus dexamethasone in treatment-naive primary immune thrombocytopenia: a multicentre, randomised, open-label, phase 2 trial. Lancet Haematol. 2021 Apr;8(4):e289-e298. doi: 10.1016/S2352-3026(21)00030-2.

    PMID: 33770484DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Interventions

OseltamivirDexamethasone

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 18, 2013

Study Start

February 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

CN(1)