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NCT01873703 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome

A Phase 2 study, sponsored by Helsinn Healthcare.

Completed
Registry status
Phase 2
Development phase
102
Enrollment target

NCT01873703: Completed Phase 2 study, sponsored by Helsinn Healthcare.

NCT01873703 is a Phase 2 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01873703, a Phase 2 study, has completed, sponsored by Helsinn Healthcare.

COMPLETED
Registry status
Phase 2
Development phase
102 participants
Enrollment target

Study Summary

The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treatment for Myelodysplastic Syndrome (MDS).

Primary Outcome

Estimate the relative efficacy, measured by complete remission rate of treatment wiht pracinostat plus azacitidine versus placebo plus azacitidine

Interventions

  • DRUG Placebo
  • DRUG Azacitidine
  • DRUG pracinostat

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2013-06
Est. Completion 2016-11
Phase Phase 2
Helsinn Healthcare

18 total trials

What the finished NCT01873703 record still lists

NCT01873703 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01873703 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01873703 about?

NCT01873703 is a clinical study titled "Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome". The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treatment for Myelodysplastic Syndrome (MDS).

What is the current status of trial NCT01873703?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2013-06. Estimated completion is 2016-11.

What interventions are being tested in trial NCT01873703?

The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), pracinostat (DRUG).

Who is sponsoring clinical trial NCT01873703?

This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01873703's enrollment target sits among peer trials

102 668th of 2000 higher than 1,329 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 NCT01873703, the US trial registry maintained by the National Library of Medicine. NCT01873703 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.