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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: Completed Phase 3 study, sponsored by Incyte Corporation.
NCT01243944 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 222 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32).
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 |
What the finished NCT01243944 record still lists
NCT01243944 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which ruxolitinib tablets is the first listed.
NCT01243944 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01243944's enrollment target sits among peer trials
222 1317th of 2000 higher than 683 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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