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NCT02009761 · ClinicalTrials.gov registry record · Phase 1

Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).

A Phase 1 study, sponsored by Boehringer Ingelheim.

Terminated
Registry status
Phase 1
Development phase
6
Enrollment target

NCT02009761: Clinical Trial Phase 1 study, sponsored by Boehringer Ingelheim.

NCT02009761 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02009761, a Phase 1 study, was terminated before completion, sponsored by Boehringer Ingelheim.

TERMINATED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.

Primary Outcome

This outcome measure presents number of patients with a response in platelet count. Response was defined as: \[A\] An increase in platelet count by greater than 20 x 10\^9/L from baseline at any time-point between Week 1 and Week 12, and \[B\] Platelet count above 50 x 10\^9/L at any time point between Week 1 and Week 12 with no rescue therapy. Baseline was defined as the platelet count at Visit 2 before administration of BI 655064. In case the patient fulfilled only one of the conditions, he/

Interventions

  • DRUG BI 655064

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2013-12-18
Est. Completion 2016-04-26
Phase Phase 1
Boehringer Ingelheim

515 total trials

Why NCT02009761 stopped before completion

NCT02009761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which BI 655064 is the first listed.

NCT02009761 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02009761 about?

NCT02009761 is a clinical study titled "Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).". BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.

What is the current status of trial NCT02009761?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-12-18. Estimated completion is 2016-04-26.

What interventions are being tested in trial NCT02009761?

The interventions under investigation include: BI 655064 (DRUG).

Who is sponsoring clinical trial NCT02009761?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02009761's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02009761, the US trial registry maintained by the National Library of Medicine. NCT02009761 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.