P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

NCT00603642 | Completed Phase 3 Results

• 1 other identifier: 20060216
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

AMG 531; Idiopathic Thrombocytopenic Purpura; ITP; Thrombocytopenia; Japan; Placebo controlled; Phase 3

Outcome Measures

Primary Outcomes (1)

• Weeks With Weekly Platelet Response

  Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10\^9/L on a weekly scheduled dose day from week 2 to week 13.

  12 weeks (Weeks 2 - 13)

Secondary Outcomes (4)

• Increased Platelet Count From Baseline of at Least 20 x 10^9/L

  Baseline, 12 weeks (Weeks 2 - 13)

• Change From Baseline in Mean of Last 4 Weekly Platelet Counts

  12 weeks (Weeks 2 - 13)

• Weeks With Platelet Count Between 50 and 200

  12 weeks (Weeks 2 - 13)

• Rescue Medication(s)

  12 weeks (Weeks 2 - 13)

Study Arms (2)

AMG 531

PLACEBO COMPARATOR

Double blinded placebo-controlled study

Drug: AMG 531

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Subcutaneously administered, once a week, for 12 weeks

Placebo

AMG 531 DRUG

Subcutaneously administered, once a week, for 12 weeks

AMG 531

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of Health, Labour and Welfare \[MHLW\] (revised in 1990) at least 6 months before the first screening visit
• The mean of the 3 scheduled platelet counts taken at the scheduled visits during the screening period must be ≤ 30 x 10\^9/L, with no individual count \> 35 x 10\^9/L
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Subjects must be ≥ 20 years of age at the time of obtaining the informed consent
• Have received at least 1 prior treatment for ITP
• If known Helicobacter pylori positive, having completed one course of Helicobacter pylori eradication therapy at least 12 weeks before the first screening visit
• A hemoglobin value taken at scheduled visit during the screening period must be ≥ 10 g/dL
• A serum creatinine concentration taken at scheduled visit during the screening period must be ≤ 2 mg/dL
• Adequate liver function, as evidenced by a total bilirubin taken at scheduled visit during the screening period ≤ 1.5 times of the upper limit of the normal range (except for patients with a confirmed diagnosis of Gilbert's Disease) or an alanine aminotransferase and aspartate aminotransferase taken at the screening visit ≤ 3 times of the upper limit of the normal range

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.
• 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 the first screening visit.
• Documented diagnosis of arterial thrombosis (eg, stroke, transient ischemic attack, or myocardial infarction); history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy at the first screening visit.
• Documented diagnosis of anti phospholipid antibody syndrome
• Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the first screening visit
• Received intravenous immunoglobulin, anti D immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants except azathioprine) within 2 weeks before the first screening visit
• Have had a splenectomy for any reason within 12 weeks before the first screening visit
• Past or present participation in any study evaluating pegacaristim (polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor, KRN9000), Eltrombopag (SB 497115), recombinant human thrombopoietin, AMG 531, or other Mpl stimulation product
• Received hematopoietic growth factors (eg, granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the first screening visit
• Received any anti malignancy agents (eg, cyclophosphamide, 6 mercaptopurine, vincristine, vinblastine, Interferon alfa) for any reason within 8 weeks before the first screening visit
• Received any monoclonal antibody drugs (eg, rituximab) for any reason within 14 weeks before the first screening visit
• Less than 4 weeks since receipt of any therapeutic drug or device that is not MHLW approved for any indication before the first screening visit
• Pregnant or breast feeding
• Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
• Known severe drug hypersensitivity

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia

Interventions

romiplostim

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 29, 2008
• Study Start: October 1, 2007
• Primary Completion: April 13, 2009
• Study Completion: April 13, 2009
• Last Updated: November 8, 2022
• Results First Posted: December 10, 2010

Record last verified: 2022-11