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NCT01227577 · ClinicalTrials.gov registry record · Phase 4
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 128
- Enrollment target
NCT01227577 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 128 participants.
The verdict
NCT01227577, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 128 participants
- Enrollment target
Study Summary
"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."
Interventions
- DRUG Nilotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01227577
The ClinicalTrials.gov registry entry for NCT01227577 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nilotinib is the first listed.
NCT01227577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01227577 about?
NCT01227577 is a clinical study titled "CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib". "This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to ...
What is the current status of trial NCT01227577?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2010-11. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01227577?
The interventions under investigation include: Nilotinib (DRUG).
Who is sponsoring clinical trial NCT01227577?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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