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High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP

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ClinicalTrials.gov Identifier: NCT01976195
Recruitment Status : Withdrawn (No eligible patient was enrolled.)
First Posted : November 5, 2013
Last Update Posted : April 20, 2016
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
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of thalidomide combining with high-dose dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone mono-therapy.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Dexamethasone Drug: Thalidomide Phase 2

Detailed Description:

The investigators are undertaking a multicenter, randomized controlled trial of 200 primary ITP adult patients from 5 medical centers in China. One part of the participants are randomly selected to receive Thalidomide (given at a dose of 150mg for 15 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 thalidomide combining with high-dose dexamethasone therapy compared to high-dose dexamethasone for the treatment of adults with ITP.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized Multicenter Investigation of High-dose Dexamethasone Combining Thalidomide Versus High-dose Dexamethasone Mono-therapy for Management of Newly-diagnosed Immune Thrombocytopenia
Study Start Date : October 2013
Estimated Primary Completion Date : December 2014


Arm Intervention/treatment
Experimental: Thalidomide plus HD-Dexmamethasone
Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days
Drug: Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days

Drug: Thalidomide
Thalidomide 150mg per day, 15 consecutive days

Active Comparator: Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days
Drug: Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days




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:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 hepatitis C virus, 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): NCT01976195


Locations
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China, Shandong
Qilu hospital, Shandong University
Jinan, Shandong, China, 250012
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
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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT01976195    
Other Study ID Numbers: ITP-Thalidomide
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: October 2013
Keywords provided by Ming Hou, Shandong University:
Thalidomide
Dexamethasone
ITP
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thalidomide
Dexamethasone
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
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents