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

NCT01976195 | Withdrawn Phase 2 DMC

• 1 other identifier: ITP-Thalidomide
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Keywords

Thalidomide; Dexamethasone; ITP

Outcome Measures

Primary Outcomes (1)

• Evaluation of platelet response

  R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia

  Newly diagnosed ITP in 3 months

Study Arms (2)

Thalidomide plus HD-Dexmamethasone

EXPERIMENTAL

Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days

Drug: Dexamethasone; Drug: Thalidomide

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 40 mg per day, 4 consecutive days

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone 40 mg per day, 4 consecutive days

Dexamethasone; Thalidomide plus HD-Dexmamethasone

Thalidomide DRUG

Thalidomide 150mg per day, 15 consecutive days

Thalidomide plus HD-Dexmamethasone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 hepatitis C virus, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Sponsors & Collaborators

• Shandong University: lead
• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: collaborator
• Anhui Medical University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Dexamethasone; Thalidomide

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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 21, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: April 20, 2016

Record last verified: 2013-10

Locations

CN (1)