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

NCT02338414 | Unknown Phase 2

• 1 other identifier: NPT-I001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Romiplostim

OTHER

Patients receiving romiplostim due to ITP

Drug: Romiplostim

Interventions

Romiplostim DRUG

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

Also known as: Nplate

Romiplostim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has an ability to provide written informed consent prior to participating to the study
• Subject is male or female ≥ 18 years of age
• Subject has a diagnosis of immune thrombocytopenia (ITP) per the American Society of Hematology guidelines.
• 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.)
• If subject had ever received TPO receptor agonist before, the patient can participate this study only after 8 weeks' wash out period

You may not qualify if:

• Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
• Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product within 8 weeks
• Subject has a known hypersensitivity to any recombinant E coli-derived product
• 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
• Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
• Subject is pregnant or breast feeding

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Jong Wook Lee, M.D.

  Seoul St. Mary's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ho Jang, M.D. Ph.D.

CONTACT

+82-2-3410-0918; smcjunhojang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 14, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 14, 2015

Record last verified: 2015-01