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NCT01243944 · ClinicalTrials.gov registry record · Phase 3

Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)

A Phase 3 study, sponsored by Incyte Corporation.

Completed
Registry status
Phase 3
Development phase
222
Enrollment target

NCT01243944 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 222 participants.

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The verdict

NCT01243944, a Phase 3 study, has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 3
Development phase
222 participants
Enrollment target

Study Summary

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

Interventions

  • DRUG ruxolitinib tablets
  • OTHER Best Available Therapy (BAT)

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2010-10-27
Est. Completion 2018-02-09
Phase Phase 3

Sponsor

Incyte Corporation

239 total trials

What the Registry Record Tells You About NCT01243944

The ClinicalTrials.gov registry entry for NCT01243944 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which ruxolitinib tablets is the first listed.

NCT01243944 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01243944 about?

NCT01243944 is a clinical study titled "Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)". This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

What is the current status of trial NCT01243944?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 222 participants. The study started on 2010-10-27. Estimated completion is 2018-02-09.

What interventions are being tested in trial NCT01243944?

The interventions under investigation include: ruxolitinib tablets (DRUG), Best Available Therapy (BAT) (OTHER).

Who is sponsoring clinical trial NCT01243944?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.