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An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338414
Recruitment Status : Unknown
Verified January 2015 by Jun Ho Jang, Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Jun Ho Jang, Samsung Medical Center

Brief Summary:
The aim of this study is to evaluate the efficacy of romiplostim administered at every other week in ITP patients who attained stable platelet counts ≥ 50 x 109/L for 4 consecutive weeks after weekly doses of romiplostim.

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

Detailed Description:
Regarding the determination of appropriate dose, it is well known that romiplostim resulted in dose-dependent increases in platelet counts, but required dose for raising platelet count is variable between individuals according to each patient's ability to eliminate serum romiplostim. Because of this variability, after administration of initial 1mcg/kg of romiplostim, dose adjustment is recommended based on the platelet response to given dose of romiplostim. However, the optimal dose interval of romiplostim has rarely been studied. In pivotal studies, romiplostim was administered on a weekly schedule, and based on these studies, one dose at every week is being widely used. In one study in which ITP patients received weekly subcutaneous doses of romiplostim at a range from 3 to 15mcg/kg, half life of romiplostim was estimated from 1 to 34 days, suggesting that lengthening the interval between doses more than a week can be potentially possible in some patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Observational Study to Evaluate the Efficacy of Romiplostim Administered at Every Other Week in Adult Patients With Chronic Immune Thrombocytopenia (ITP) Who Attained Platelet Counts ≥ 50 x 109/L After Weekly Doses of Romiplostim
Study Start Date : January 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016


Arm Intervention/treatment
Romiplostim
Patients receiving romiplostim due to ITP
Drug: Romiplostim
Subcutaneous Romiplostim (weekly injection) -> if titrated with maintaining PLT count between 50-200 x 10^9/L -> Subcutaneous Romiplostim (biweekly injection)
Other Name: Nplate




Primary Outcome Measures :
  1. Efficacy of biweekly romiplostim (platelet counts ≥ 30 x 10^9/L) [ Time Frame: up to 24 weeks ]
    To evaluate the proportion of patients who had platelet counts ≥ 30 x 109/L during 4 or more weeks with biweekly romiplostim



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has an ability to provide written informed consent prior to participating to the study
  2. Subject is male or female ≥ 18 years of age
  3. Subject has a diagnosis of immune thrombocytopenia (ITP) per the American Society of Hematology guidelines.
  4. Subject received at least 1 prior therapy for ITP including corticosteroids, immunoglobulin, or splenectomy, but had an insufficient response to any of these treatment (PLT count should be < 30x109/L before romiplostim initiation.)
  5. If subject had ever received TPO receptor agonist before, the patient can participate this study only after 8 weeks' wash out period

Exclusion Criteria:

  1. Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
  2. Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product within 8 weeks
  3. Subject has a known hypersensitivity to any recombinant E coli-derived product
  4. Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
  5. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
  6. Subject is pregnant or breast feeding

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): NCT02338414


Contacts
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Contact: Jun Ho Jang, M.D. Ph.D. +82-2-3410-0918 smcjunhojang@gmail.com

Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jong Wook Lee, M.D. Seoul St. Mary's Hospital, The Catholic University of Korea
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Responsible Party: Jun Ho Jang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02338414    
Other Study ID Numbers: NPT-I001
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
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