rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP

This study has been completed.
Sponsor:
Collaborators:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Anhui Medical University
The First Affiliated Hospital of Dalian Medical University
Shandong Provincial Hospital
Shenzhen Second People's Hospital
China Medical University, China
Zhejiang Provincial Hospital of TCM
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01734044
First received: November 21, 2012
Last updated: April 18, 2016
Last verified: November 2012
  Purpose
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.

Condition Intervention Phase
Purpura
Idiopathic Thrombocytopenic Purpura
Drug: recombinant human thrombopoietin (rhTPO); dexamethasone
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Evaluation of platelet response [ Time Frame: up to 1 year per subject ] [ Designated as safety issue: Yes ]
    Chronic ITP is defined as having platelet count less than 100×10^9/L,lasting for more than 12 months.

  • Evaluation of platelet response (R) [ Time Frame: up to 1 year per subject ] [ Designated as safety issue: Yes ]
    R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia


Enrollment: 158
Study Start Date: July 2012
Study Completion Date: November 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: combination treatment group
100 enrolled patients are randomly picked up to take rhTPO in combination with dexamethasone at the indicated dose.
Drug: recombinant human thrombopoietin (rhTPO); dexamethasone
Patients in recombination treatment group take rhTPO( subcutaneously , 300U/kg for 14 consecutive days, followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days)
Other Names:
  • Recombinant Human Thrombopoietin
  • Recombinant Human TPO
  • rhTPO combine with Dexamethasone
  • Recombinant Human Thrombopoietin combine with Dexamethasone
  • Recombinant Human TPO combine with Dexamethasone
Active Comparator: single treatment group
100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.
Drug: Dexamethasone
Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.

Detailed Description:
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 200 primary ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4days, 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 was evaluated before and after treatment, in order to report the conversion ratio of primary ITP to chronic ITP.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet the diagnostic criteria for immune thrombocytopenia.
  2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
  3. To show a platelet count < 30×10^9/L, and with bleeding manifestations.
  4. Eastern Cooperative Oncology Group(ECOG)performance status ≤ 2.
  5. Willing and able to sign written informed consent.

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  2. Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
  3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
  5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  6. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
  7. Patients who are deemed unsuitable for the study by the investigator.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01734044

Locations
China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China
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
Shandong Provincial Hospital
Shenzhen Second People's Hospital
China Medical University, China
Zhejiang Provincial Hospital of TCM
Investigators
Principal Investigator: Ming Hou, Dr. Shandong University
  More Information

Publications:

Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT01734044     History of Changes
Other Study ID Numbers: ITP-007 
Study First Received: November 21, 2012
Last Updated: April 18, 2016
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Recombinant Human Thrombopoietin
rhTPO
Dexamethasone

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
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

ClinicalTrials.gov processed this record on July 24, 2016