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Trial record 31 of 42 for:    Recruiting Studies | ITP

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

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ClinicalTrials.gov Identifier: NCT01965626
Recruitment Status : Recruiting
First Posted : October 18, 2013
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Anhui Medical University
The First Affiliated Hospital of Dalian Medical University
Shenzhen Second People's Hospital
Zhejiang Provincial Hospital of TCM
Information provided by (Responsible Party):
Ming Hou, Shandong University

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 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.

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 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 receiver HD-DXM (orally at 40 mg daily for 4d as one cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 8, an additional four-day cycle of dexamethasone was given.) 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 as one cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 8, an additional four-day cycle of dexamethasone was given.) alone.

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 with high platelet desialylation level.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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 With High Platelet Desialylation Level
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019


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 as one cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional four-day cycle of dexamethasone was given.)

Drug: Oseltamivir
Oseltamivir 75 mg twice per day, 10 consecutive days

Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d as one cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional four-day cycle of dexamethasone was given.)

Active Comparator: HD-DXM
HD-DXM (orally at 40 mg daily for 4d as one cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional four-day cycle of dexamethasone was given.)
Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d as one cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional four-day cycle of dexamethasone was given.)




Primary Outcome Measures :
  1. Evaluation of platelet response [ Time Frame: Newly diagnosed ITP in 3 months ]
    R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965626


Contacts
Contact: Ming Hou, Docter houming@medmail.com.cn

Locations
China, Shandong
Qilu hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou       houming@medmail.com.cn   
Principal Investigator: Ming Hou         
Sponsors and Collaborators
Shandong University
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Anhui Medical University
The First Affiliated Hospital of Dalian Medical University
Shenzhen Second People's Hospital
Zhejiang Provincial Hospital of TCM

Publications of Results:
Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT01965626     History of Changes
Other Study ID Numbers: ITP-Oseltamivir
ITP-Oseltamivirphosphate ( Registry Identifier: ITP-Oseltamivirphosphate )
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ming Hou, Shandong University:
Oseltamivir
Dexamethasone
ITP

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Oseltamivir
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents