18 and older, any sex, with Hematology or MDS. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Summary of Adverse EventsPrimary· During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .
Subjects Reporting Any AE
Group
Value
95% CI
Romiplostim
71
Subjects Reporting Any Treatment-related AE
Group
Value
95% CI
Romiplostim
19
Subjects Reporting Any Treat-related Serious AE
Group
Value
95% CI
Romiplostim
4
Subjects Reporting Any Serious AE
Group
Value
95% CI
Romiplostim
29
Subjects Withdrew Study or Stop IP Due to AE
Group
Value
95% CI
Romiplostim
8
Weekly Bleeding Events Per 100 Subject YearsSecondary· During the treatment period. The average duration of romiplostim exposure is 56 weeks.
During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day.
Group
Value
95% CI
Romiplostim
1120.5
1047.1 – 1197.7
Platelet Transfusion Events Per 100 Subject YearsSecondary· During the treatment period. The average duration of romiplostim exposure is 56 weeks.
During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events.
Group
Value
95% CI
Romiplostim
204.4
173.8 – 238.9
Weeks With Platelet Response Per YearSecondary· During the treatment period. The average duration of romiplostim exposure is 56 weeks.
During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10\^9/L for a subject starting with a platelet count of ≥ 20 x 10\^9/L; or an increase in platelet count from \< 20 x 10\^9/L to ≥ 20 x 10\^9/L and by at least 100% in a subject that started with a platelet count \< 20 x 10\^9/L.
Group
Value
95% CI
Romiplostim
34.6
33.3 – 35.9
Time to First Platelet ResponseSecondary· During treatment period. The average duration of romiplostim exposure is 56 weeks.
Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10\^9/L for a subject starting with a platelet count of ≥ 20 x 10\^9/L; or an increase in platelet count from \< 20 x 10\^9/L to ≥ 20 x 10\^9/L and by at least 100% in a subject that started with a platelet count \< 20 x 10\^9/L.
Group
Value
95% CI
Romiplostim
2.3
2.1 – 3.1
Duration of Platelet ResponseSecondary· During treatment period. The average duration of romiplostim exposure is 56 weeks.
Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10\^9/L for a subject starting with a platelet count of ≥ 20 x 10\^9/L; or an increase in platelet count from \< 20 x 10\^9/L to ≥ 20 x 10\^9/L and by at least 100% in a subject that started with a platelet count \< 20 x 10\^9/L.
Group
Value
95% CI
Romiplostim
20.0
1 – 159
Incidence of Antibody (AB) FormationPrimary· During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks.
Positive binding AB to IP at or before baseline
Group
Value
95% CI
Romiplostim
5
± 94.7
Neutralizing AB to IP at or before baseline
Group
Value
95% CI
Romiplostim
0
Binding AB positive to IP post-baseline only
Group
Value
95% CI
Romiplostim
5
Persistent binding AB positive to IP
Group
Value
95% CI
Romiplostim
4
Transient binding AB positive to IP
Group
Value
95% CI
Romiplostim
1
Positive binding AB to TPO at or before baseline
Group
Value
95% CI
Romiplostim
4
Neutralizing AB to TPO at or before baseline
Group
Value
95% CI
Romiplostim
0
Binding AB positive to TPO post-baseline only
Group
Value
95% CI
Romiplostim
3
Adverse events — posted to ClinicalTrials.gov
Time frame: The average duration is 56 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10\^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 29 December 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00472290.