A Phase 3 interventional study of Darbepoetin Alfa in Myelodysplastic Syndrome (MDS), sponsored by Amgen. Completed at 4 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 9 is below the median of 36 across 1,060 interventional studies indexed under Preleukemia.
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Exclusion Criteria:
Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
Drug: Darbepoetin Alfa
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).
Also known as: Aranesp®
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: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event The investigator assessed whether each adverse events was related to darbepoetin alfa.
Time frame: From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.
This study was conducted at 5 centers in Belgium from 12 June 2014 (first participant enrolled) to 20 March 2017 (last participant completed study).
| Milestone | Darbepoetin Alfa |
|---|---|
| Started | 9 |
| Completed | 8 |
| Not completed | 1 |
| Withdrew: Protocol-specified criteria | 1 |
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: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event The investigator assessed whether each adverse events was related to darbepoetin alfa.
| Participants | Darbepoetin Alfa |
|---|---|
| All adverse events | 9 |
| Adverse events ≥ grade 2 | 8 |
| Adverse events ≥ grade 3 | 2 |
| Adverse events ≥ grade 4 | 0 |
| Serious adverse events | 3 |
| AEs leading to discontinuation of darbepoetin alfa | 1 |
| Fatal adverse events | 0 |
| Treatment-related adverse events | 0 |
Collected over From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Darbepoetin Alfa | 0/9 (0%) | 3/9 (33.3%) | 9/9 (100%) |
| Event | Darbepoetin Alfa |
|---|---|
| Macular fibrosisEye disorders | 1/9 |
| PyrexiaGeneral disorders | 1/9 |
| Ischaemic strokeNervous system disorders | 1/9 |
| Event | Darbepoetin Alfa |
|---|---|
| FatigueGeneral disorders | 4/9 |
| Dyspnoea exertionalRespiratory, thoracic and mediastinal disorders | 4/9 |
| Abdominal discomfortGastrointestinal disorders | 3/9 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/9 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 3/9 |
| AnaemiaBlood and lymphatic system disorders | 2/9 |
| NasopharyngitisInfections and infestations | 2/9 |
| Bone painMusculoskeletal and connective tissue disorders | 2/9 |
| DizzinessNervous system disorders | 2/9 |
| HeadacheNervous system disorders | 2/9 |
| Age, Continuous(years) | Darbepoetin Alfa |
|---|---|
| Mean | 71.3 ± 7.9 |
| Age, Customized(Participants) | Darbepoetin Alfa |
|---|---|
| 18 - 64 years | 1 |
| 65 - 74 years | 6 |
| 75 - 84 years | 2 |
| ≥ 85 years | 0 |
| Sex: Female, Male(Participants) | Darbepoetin Alfa |
|---|---|
| Female | 3 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Darbepoetin Alfa |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Darbepoetin Alfa |
|---|---|
| White | 9 |
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