Trial record 1 of 1 for:    20080279
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Safety and Efficacy Study of Romiplostim to Treat ITP in Pediatric Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01444417
First received: September 29, 2011
Last updated: October 16, 2014
Last verified: October 2014

September 29, 2011
October 16, 2014
December 2011
March 2015   (final data collection date for primary 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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01444417 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • number of weekly platelet counts ≥ 50 x 10^9/L during weeks 2 to 25 of the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • incidence of rescue ITP medications used [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • incidence of adverse events, including thromboembolic events and hematologic malignancies, clinically significant changes in laboratory values and the incidence of antibody formation [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Romiplostim to Treat ITP in Pediatric Subjects
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
  • Drug: romiplostim
    The starting dose of romiplostim is 1 µg/kg administered weekly by subcutaneous injection. Subjects will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10^9/L and ≤ 200 x 10^9/L.
  • Drug: Placebo
    The starting dose is 1 µg/kg administered weekly by subcutaneous injection. Subjects will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10^9/L and ≤ 200 x 10^9/L.
  • Experimental: romiplostim
    romiplostim (AMG 531)
    Intervention: Drug: romiplostim
  • Placebo Comparator: Placebo
    Placebo Comparator
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
62
September 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
1 Year to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT01444417
20080279, 2010-018426-39
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP