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Trial record 13 of 554 for:    Thrombocytopenia: Clinical Trials

Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy

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ClinicalTrials.gov Identifier: NCT02270801
Recruitment Status : Unknown
Verified March 2016 by Ming Hou, Shandong University.
Recruitment status was:  Recruiting
First Posted : October 21, 2014
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

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

Detailed Description:
The investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP)in Pregnancy: a Single-center Clinical Trial
Study Start Date : October 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2017


Arm Intervention/treatment
Experimental: rhTPO
rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.
Drug: rhTPO
rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.
Other Names:
  • TPIAO
  • S20050048/49 (SFDA, China)




Primary Outcome Measures :
  1. Early Response [ Time Frame: one month after delivery ]
    Response rate (CR+R) at the 14th day, the 10th week from the initial injection of rhTPO, ante partum and one month after delivery. CR is defined as platelet count ≥ 100×109/L, and R is defined as platelet count of >30×109/L with at least a doubling of the baseline value.


Secondary Outcome Measures :
  1. Safety [ Time Frame: six months after delivery ]
    Adverse events in patients and infants.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is between 18-50 years old.
  2. After 12 weeks gestation.
  3. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
  4. Patients who have no response or relapsed after Corticosteroid or IVIG.
  5. Patients developed refractoriness to platelet transfusion.
  6. To show a platelet count < 30×10^9/L, and with bleeding manifestations.
  7. 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 second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  4. 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)
  5. 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.
  6. 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): NCT02270801


Contacts
Contact: Ming Hou, MD PhD 86-531-82169114 ext 9879 houming@medmail.com.cn

Locations
China, Shandong
Shandong University Qilu hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou, MD PhD    +86-531-82169114 ext 9879    houming@medmail.com.cn   
Principal Investigator: Ming Hou         
Sponsors and Collaborators
Shandong University
Investigators
Principal Investigator: Ming Hou, MD PhD Shandong University

Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT02270801     History of Changes
Other Study ID Numbers: rhTPO-ITP-Pregnancy
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: March 2016

Keywords provided by Ming Hou, Shandong University:
recombinant human thrombopoietin
immune thrombocytopenia
pregnancy

Additional relevant MeSH terms:
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