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NCT01143038 · ClinicalTrials.gov registry record · Phase 2

Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim

A Phase 2 study, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target

NCT01143038: Completed Phase 2 study, sponsored by Amgen.

NCT01143038 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01143038, a Phase 2 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.

Primary Outcome

The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10\^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.

Interventions

  • BIOLOGICAL Romiplostim

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2010-11-30
Est. Completion 2013-12-26
Phase Phase 2
Amgen

558 total trials

What the finished NCT01143038 record still lists

NCT01143038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 1 intervention - of which Romiplostim is the first listed.

NCT01143038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01143038 about?

NCT01143038 is a clinical study titled "Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim". The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.

What is the current status of trial NCT01143038?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2010-11-30. Estimated completion is 2013-12-26.

What interventions are being tested in trial NCT01143038?

The interventions under investigation include: Romiplostim (BIOLOGICAL).

Who is sponsoring clinical trial NCT01143038?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01143038's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01143038, the US trial registry maintained by the National Library of Medicine. NCT01143038 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.