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)
Public ClinicalTrials.gov record NCT01243944. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01243944
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2010 (Actual)
- Primary completion
- Jan 15, 2014 (Actual)
- Completion
- Feb 9, 2018 (Actual)
- Last update posted
- Mar 6, 2019
2010 – 2018
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Scottsdale | Arizona | — | — |
| Not listed | Pomona | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Bridgeport | Connecticut | — | — |
| Not listed | New Haven | Connecticut | — | — |
| Not listed | Boynton Beach | Florida | — | — |
| Not listed | Fort Myers | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Winter Park | Florida | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Lafayette | Louisiana | — | — |
| Not listed | Scarborough | Maine | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Columbia | Maryland | — | — |
| Not listed | Southfield | Michigan | — | — |
| Not listed | Jefferson City | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Morristown | New Jersey | — | — |
| Not listed | Somerville | New Jersey | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Greenville | South Carolina | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01243944, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 6, 2019 · Synced Oct 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01243944 live on ClinicalTrials.gov.