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

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

Intervention: Placebo (Drug); AMG 531 (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 and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .

Clinical Details

Official title: A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

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

Primary outcome: Weeks With Weekly Platelet Response

Secondary outcome:

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

Change From Baseline in Mean of Last 4 Weekly Platelet Counts

Weeks With Platelet Count Between 50 and 200

Rescue Medication(s)

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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

- Concerns for subject's compliance with the protocol

Locations and Contacts

Additional Information

Notice regarding posted summaries of trial results

AmgenTrials clinical trials website

Starting date: October 2007
Last updated: February 4, 2011

Page last updated: August 23, 2015

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