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Safety and Efficacy Study of Romiplostim to Treat ITP in Pediatric Subjects

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic Purpura; Immune Thrombocytopenia

Intervention: romiplostim (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric subjects with Immune Thrombocytopenia Purpura (ITP) as measured by durable platelet response.

Clinical Details

Official title: A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: incidence of durable platelet response defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10^9/L during weeks 18 through 25 of treatment

Secondary outcome:

incidence of overall platelet response defined as subjects who achieve a platelet count ≥ 50 x 10^9/L at a minimum of 4 times during weeks 2 to 25 of the treatment period

number of weekly platelet counts ≥ 50 x 10^9/L during weeks 2 to 25 of the treatment period

incidence of rescue ITP medications used

number of composite bleeding episodes defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinically significant bleeding event during weeks 2 to 25 of the treatment period

incidence of adverse events, including thromboembolic events and hematologic malignancies, clinically significant changes in laboratory values and the incidence of antibody formation

Eligibility

Minimum age: 1 Year. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of primary ITP according to the ASH Guidelines at least 6 months prior to

screening, regardless of splenectomy status

- Subject must be refractory to a prior ITP therapy, having relapsed after at least 1

prior ITP therapy, or ineligible for other ITP therapies; prior therapy includes first-line therapies

- Age ≥ 1 year and < 18 years at the time of providing informed consent

- The mean of 2 platelet counts taken during the screening period must be ≤ 30 x 10^9/L

with neither count > 35 x 10^9/L

- A serum creatinine concentration ≤ 1. 5 times the laboratory normal range (for each

age category) during the screening period

- Adequate liver function; serum bilirubin ≤ 1. 5 times the laboratory normal range

during the screening period;AST and ALT ≤ 3. 0 times the laboratory normal range during the screening period

- Hemoglobin > 10. 0 g/dL during the screening period

- Subject and/or subject's legally acceptable representative has provided informed

consent prior to any study-specific procedure; subject has provided assent, where required Exclusion Criteria:

- Known history of a bone marrow stem cell disorder; any abnormal bone marrow findings

other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study

- Known active or prior malignancy except adequately treated basal cell carcinoma

- Known history of congenital thrombocytopenia

- Known history of hepatitis B, hepatitis C, or HIV

- Known history of H. pylori by urea breath test or stool antigen test within 6 months

of enrollment or successfully treated with no evidence of infection

- Known history of systemic lupus erythematosus, evans syndrome, or autoimmune

neutropenia

- Known history of antiphospholipid antibody syndrome or positive for lupus

anticoagulant

- Known history of disseminated intravascular coagulation, hemolytic uremic syndrome,

or thrombotic thrombocytopenic purpura

- Previous history of venous thromboembolism or thrombotic events

- Previous use of romiplostim, PEG-rHuMGDF, Eltrombopag, rHuTPO or any platelet

producing agent

- Rituximab (for any indication) or 6-MP within 14 weeks before the screening visit, or

anticipated use during the time of the proposed study

- Splenectomy within 4 weeks of the screening visit

- All hematopoietic growth factors including IL-11 (oprelvekin) within 4 weeks before

the screening visit

- Alkylating agents within 8 weeks before the screening visit or anticipated use during

the time of the proposed study

- Vaccinations known to decrease platelet counts within 8 weeks before the screening

visit

- Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen,

Neupogen, Somatropin, and Actimmune)

- Other criteria may apply

Locations and Contacts

Research Site, Orange, California 92868, United States

Research Site, San Diego, California 92123, United States

Research Site, Washington, District of Columbia 20010, United States

Research Site, Atlanta, Georgia 30322, United States

Research Site, Chicago, Illinois 60611, United States

Research Site, Peoria, Illinois 61615, United States

Research Site, Indianapolis, Indiana 46260, United States

Research Site, Iowa City, Iowa 52242, United States

Research Site, Louisville, Kentucky 40202, United States

Research Site, New Orleans, Louisiana 70118, United States

Research Site, Detroit, Michigan 48201, United States

Research Site, Kansas City, Missouri 64108, United States

Research Site, Omaha, Nebraska 68114, United States

Research Site, Las Vegas, Nevada 89109, United States

Research Site, New Brunswick, New Jersey 08901, United States

Research Site, Randwick, New South Wales 2031, Australia

Research Site, New York, New York 10016, United States

Research Site, New York, New York 10021, United States

Research Site, Cincinnati, Ohio 45229, United States

Research Site, Columbus, Ohio 43205, United States

Research Site, Hamilton, Ontario L8S 4K1, Canada

Research Site, Toronto, Ontario M5G 1X8, Canada

Research Site, Philadelphia, Pennsylvania 19104, United States

Research Site, Pittsburgh, Pennsylvania 15224, United States

Research Site, Montreal, Quebec H3H 1P3, Canada

Research Site, Montreal, Quebec H3T 1C5, Canada

Research Site, Quebec City, Quebec G1V 4G2, Canada

Research Site, Herston, Queensland 4029, Australia

Research Site, Nashville, Tennessee 37232, United States

Research Site, Fort Worth, Texas 76104, United States

Research Site, Houston, Texas 77030, United States

Research Site, Parkville, Victoria 3052, Australia

Research Site, La Crosse, Wisconsin 54601, United States

Additional Information

AmgenTrials clinical trials website

Starting date: December 2011
Last updated: July 13, 2015

Page last updated: August 23, 2015

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