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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2010-10-27 |
| Est. Completion | 2018-02-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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