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

Immune Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02338414
• Other study ID #: NPT-I001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 6, 2015
• Last updated: January 11, 2015
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Samsung Medical Center
• Contact: Jun Ho Jang, M.D. Ph.D.
• Phone: +82-2-3410-0918
• Email: smcjunhojang[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• Romiplostim
Subcutaneous Romiplostim (weekly injection) -> if titrated with maintaining PLT count between 50-200 x 10^9/L -> Subcutaneous Romiplostim (biweekly injection)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of biweekly romiplostim (platelet counts = 30 x 10^9/L)	To evaluate the proportion of patients who had platelet counts = 30 x 109/L during 4 or more weeks with biweekly romiplostim	up to 24 weeks	Yes