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Thrombocytopenia in Gestational Period

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ClinicalTrials.gov Identifier: NCT02751593
Recruitment Status : Unknown
Verified April 2016 by Peking University People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Pregnancy Drug: Dexamethasone Phase 2 Phase 3

Detailed Description:
The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thrombocytopenia in Gestational Period
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: dexamethasone
dexamethasone 40mg/d for 4 days
Drug: Dexamethasone
dexamethasone 40mg/d for 4 days




Primary Outcome Measures :
  1. Response rate (CR+R) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Platelet count [ Time Frame: 2 years ]
  2. Adverse events [ Time Frame: 2 years ]
  3. live birth rate [ Time Frame: 2 years ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is between 20-50 years old.
  • After 12 weeks gestation.
  • Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
  • Patients who have no response or relapsed after Corticosteroid or IVIG.
  • Patients developed refractoriness to platelet transfusion.
  • To show a platelet count < 30×10^9/L, and with bleeding manifestations.
  • Willing and able to sign written informed consent.

Exclusion Criteria:

  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  • Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  • Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  • Severe medical condition (lung, hepatic or renal disorder) other than chronic 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).
  • 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.
  • Patients who are deemed unsuitable for the study by the investigator.

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): NCT02751593


Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Chair: Xiao-hui Zhang, Dr Peking University People's Hospital

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02751593     History of Changes
Other Study ID Numbers: pregnancy and thrombocytopenia
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Peking University People's Hospital:
pregnancy
Immune Thrombocytopenia
dexamethasone

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
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
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
Protease Inhibitors