NCT00102323

Brief Summary

The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

January 27, 2005

Last Update Submit

November 3, 2022

Conditions

ThrombocytopeniaIdiopathic Thrombocytopenic Purpura

Keywords

immune (idiopathic) thrombocytopenic purpurapost-splenectomyITPThrombopenia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters

    Last 8 weeks of treatment

Secondary Outcomes (3)

  • To evaluate the overall safety of AMG 531

    Entire study duration plus follow up period

  • To evaluate the possible reductions in concurrent ITP therapies while receiving AMG 531

    Entire study duration

  • To evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531

    Entire study duration

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

AMG 531

EXPERIMENTAL

Active Investigational Product

Biological: AMG 531

Interventions

PlaceboDRUG

Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.

Placebo
AMG 531BIOLOGICAL

Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

AMG 531

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ITP according to American Society of Hematology (ASH) guidelines (Appendix F)
  • Have had a splenectomy for the treatment of ITP greater than or equal to 24 weeks prior to study entry
  • Subjects greater than 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis
  • The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be:
  • \* less than 30 x 10\^9/L for those subjects not receiving any ITP therapy, with no count greater than 35 x 10\^9/L,
  • \* less than 50 x 10\^9/L for those subjects receiving a constant dose schedule of corticosteroids, azathioprine or danazol with no count greater than 55 x 10\^9/L
  • A serum creatinine concentration less than or equal to 2 mg/dl(less than or equal to 176.8 µmol/L)
  • Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range
  • Hemoglobin greater than 11.0 g/dL
  • Written informed consent (see Section 12.1)

You may not qualify if:

  • Any known history of 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)
  • Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization
  • Documented diagnosis of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) in the past year
  • History of venous thrombosis (i.e., deep vein thrombosis, pulmonary embolism) including those subjects who are on ant-coagulation therapy
  • Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[NYHA greater than class II\], uncontrolled hypertension \[diastolic greater than 100 mmHg\] or cardiac arrhythmia)
  • Have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker; using oral contraceptives; on estrogen therapy; known positive for anti-phospholipid antibodies; hypertriglyceridemia; hypercholesteremia (greater than 240 mg/dL); treatment for hypertension
  • Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
  • Currently receiving any treatment for ITP except corticosteroids, azathioprine or danazol administered at a constant dose and schedule
  • IV Ig or anti-D Ig within 2 weeks before the screening visit
  • Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study
  • Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit
  • Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531 or related platelet product
  • Received any aklylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
  • Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period
  • Less than 8 weeks since major surgery
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.

    PMID: 28411254BACKGROUND

  • Kuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.

    PMID: 30793285BACKGROUND

  • Kuter DJ, Arnold DM, Rodeghiero F, Janssens A, Selleslag D, Bird R, Newland A, Mayer J, Wang K, Olie R. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. Am J Hematol. 2020 Jun;95(6):643-651. doi: 10.1002/ajh.25776. Epub 2020 Mar 21.

    PMID: 32129511BACKGROUND

  • Weitz I, Sanz MA, Henry D, Schipperus M, Godeau B, Northridge K, Gleeson M, Danese M, Deuson R. A novel approach to the evaluation of bleeding-related episodes in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 May;28(5):789-96. doi: 10.1185/03007995.2012.684046. Epub 2012 Apr 25.

    PMID: 22494019DERIVED

  • Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Blood. 2009 Oct 29;114(18):3748-56. doi: 10.1182/blood-2009-05-224766. Epub 2009 Aug 11.

    PMID: 19671919DERIVED

  • Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH Jr, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrere F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. doi: 10.1016/S0140-6736(08)60203-2.

    PMID: 18242413DERIVED

Related Links

MeSH Terms

Conditions

ThrombocytopeniaPurpura, Thrombocytopenic, IdiopathicPurpura, Thrombocytopenic

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaPurpuraBlood Coagulation DisordersThrombotic MicroangiopathiesHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2005

First Posted

January 28, 2005

Study Start

March 29, 2005

Primary Completion

September 1, 2006

Study Completion

March 1, 2007

Last Updated

November 7, 2022

Record last verified: 2022-11