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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000727-13 | EudraCT Number |
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The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.
This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160 study (NCT01362140) for the treatment of anaemic patients with MDS. Participants who completed the active-treatment period of the darbepoetin alfa MDS 20090160 study and met the eligibility criteria could be enrolled into this study to continue treatment of darbepoetin alfa for up to 73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin Alfa | Experimental | Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin Alfa | Drug | The first dose of darbepoetin alfa was the same as that administered at the last dosing visit of the active treatment period in Study 20090160. Doses could be increased up to a maximum of 500 μg every two weeks (Q2W). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 indicates a mild AE, Grade 2 indicates a moderate AE, Grade 3 indicates severe or medically significant but not immediately life-threatening and Grade 4 indicates life-threatening consequences; urgent intervention indicated. A serious adverse event was defined as an adverse event that met at least one of the following serious criteria:
| From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Charleroi | 6000 | Belgium | |||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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This study enrolled participants who completed the active treatment period of the phase 3 Study 20090160 (NCT01362140).
This study was conducted at 5 centers in Belgium from 12 June 2014 (first participant enrolled) to 20 March 2017 (last participant completed study).
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| ID | Title | Description |
|---|---|---|
| FG000 | Darbepoetin Alfa | Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Darbepoetin Alfa | Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 indicates a mild AE, Grade 2 indicates a moderate AE, Grade 3 indicates severe or medically significant but not immediately life-threatening and Grade 4 indicates life-threatening consequences; urgent intervention indicated. A serious adverse event was defined as an adverse event that met at least one of the following serious criteria:
| All enrolled participants | Posted | Count of Participants | Participants | From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks. |
|
From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Darbepoetin Alfa | Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular fibrosis | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2014 | Mar 13, 2018 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 15, 2013 | Oct 15, 2018 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| Leuven |
| 3000 |
| Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Sint-Niklaas | 9100 | Belgium |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| Darbepoetin Alfa |
Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first. |
|
|
| 0 |
| 9 |
| 3 |
| 9 |
| 9 |
| 9 |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Chalazion | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Oral fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Restless legs syndrome | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Skin discomfort | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |