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Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
Plain-language guide to NCT00440037: phase 2, phase 3 interventional trial of Romiplostim, 44 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00440037
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2006-11
- Completion (planned or actual)
- 2011-07
- Participants
- 44 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Romiplostim.
This study is available to subjects who have completed any previous AMG 531 ITP study in Japan and meet the eligibility criteria of this study.
It had 1 arm (groups): AMG 531 (experimental).
The registry classes the interventions as biological.
More on the Plan
Romiplostim was administered by subcutaneous (SC) injection once per week.
Who Took Part
44 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Subjects must have previously completed an AMG 531 ITP study in Japan. Platelet count taken at the screening visit must be \< 50 x 109/L. Before any study-specific procedure, the appropriate written informed consent must be obtained.
The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: known positive result from a test for neutralizing antibodies to amg 531 in the previous amg 531 itp study; received anti-malignancy agents (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa etc) within 4 weeks before the screening visit; received any monoclonal antibody drugs (eg, rituximab etc) within 8 weeks before the screening visit.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2006-11 with completion listed for 2011-07.
It ran at 13 sites in Japan (13).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 4 secondary outcomes, for example Incidence of Anti AMG 531 Antibody Formation and Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose).
What This Means in Plain Language
Put simply, this is a phase 2, phase 3 trial of Romiplostim in 44 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Romiplostim compound page, all human trials.
Our Notes on the Compound
Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.