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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)


Phase 3
1 Year
17 Years
Open (Enrolling)
Both
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

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

20080279

NCT ID:

NCT01444417

Start Date:

December 2011

Completion Date:

April 2014

Related Keywords:

  • 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 (Idiopathic) Thrombocytopenic Purpura
  • Pediatric Immune (Idiopathic) Thrombocytopenic Purpura
  • Purpura
  • Purpura, Thrombocytopenic
  • Thrombocytopenia
  • Purpura, Thrombocytopenic, Idiopathic

Name

Location

Hinsdale, Illinois  60521
Research SiteAnaheim, California  
Research SiteWashington, District of Columbia  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAppleton, Wisconsin