An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00508820
First received: July 26, 2007
Last updated: January 11, 2012
Last verified: January 2012
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Purpose
This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenic Purpura |
Biological: Romiplostim |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) |
Resource links provided by NLM:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
Drug Information available for:
Romiplostim
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Adverse Events [ Time Frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. ] [ Designated as safety issue: Yes ]One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once
Secondary Outcome Measures:
- Platelet Response (Definition 1) [ Time Frame: Duration of treatment (up to 201 weeks) ] [ Designated as safety issue: No ]Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L
- Platelet Response (Definition 2) [ Time Frame: Duration of treatment (up to 201 weeks) ] [ Designated as safety issue: No ]Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)
| Enrollment: | 407 |
| Study Start Date: | February 2005 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Romiplostim
|
Biological: Romiplostim
Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.
Other Name: romiplostim
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is ≥ 18 years of age
- Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
- If Subject is > 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
- Subject has received at least 1 prior therapy for ITP
- Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
- Subject (or legally-acceptable representative) is willing and able to provide written informed consent
Exclusion Criteria:
- Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
- Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product
- Subject has a known hypersensitivity to any recombinant E coli-derived product
- Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
- Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
- Subject is pregnant or breast feeding
- Investigator has concerns regarding the subject's ability to comply with the protocol procedures
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00508820 History of Changes |
| Other Study ID Numbers: | 20040209 |
| Study First Received: | July 26, 2007 |
| Results First Received: | January 11, 2012 |
| Last Updated: | January 11, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee Australia: Therapeutic Goods Administration Australia: Department of Health and Ageing Therapeutic Goods Administration France: Ministry of Health Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information Austria: Bundesamt für Sicherheit im Gesundheitswesen Austria: Secretariat of Health Belgium: Federal Agency for Medicines and Health Products, FAMHP Belgium: Directorate-General for Medicinal Products Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment Belgium: FPS of Public Health, Food Chain Security and Environment Belgium: Pharmaceutical Inspectorate Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement Canada: Health Canada Czech Republic: State Institute for Drug Control Czech Republic: Statni ustav pro kontrolu leciv Denmark: Central Ethics Committee Denmark: Danish Medicines Agency EU: CHMP France and Sweden: European Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe United States: Western Institutional Review Board Greece: National Organization for Medicines Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Local Ethics Committees Italy: Ministry of Health Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research Netherlands: Medicines Evaluation Board Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider Norway: Norwegian Medicines Agency Poland: Drug Institut Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) Portugal: National Institute of Pharmacy and Medicines Slovakia: Ministry of Health Slovakia: State Institiute for Drug Control Spain: Spanish Drug Agency Sweden: Medical Products Agency Switzerland: Agency for Therapeutic Products Switzerland: Local Ethics Committee Switzerland: Swissmedic (Swiss Agency for Therapeutic Products) United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Amgen:
|
Platelet AMG 531 Thrombopoietin blood disorder bleeding disorder |
immune thrombocytopenic purpura idiopathic thrombocytopenic purpura immune (idiopathic) thrombocytopenic purpura TPO thrombopoietic protein |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes |
Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases |
ClinicalTrials.gov processed this record on June 18, 2013