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NCT01056393 · ClinicalTrials.gov registry record · Phase 2
Investigator-Sponsored Protocol - Continued Use of Ibalizumab
A Phase 2 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01056393 is a Phase 2 study that has completed, run by Kaiser Permanente. The registered enrollment target is 5 participants.
The verdict
NCT01056393, a Phase 2 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1 (Amended to 24 Week Study)"), for 24 weeks. Ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.
Interventions
- DRUG ibalizumab 800mg Q2Weeks
- DRUG ibalizumab 2000mg Q4Weeks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-11 |
| Est. Completion | 2016-12-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01056393
The ClinicalTrials.gov registry entry for NCT01056393 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ibalizumab 800mg Q2Weeks is the first listed.
NCT01056393 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01056393 about?
NCT01056393 is a clinical study titled "Investigator-Sponsored Protocol - Continued Use of Ibalizumab". This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Backg...
What is the current status of trial NCT01056393?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2009-11. Estimated completion is 2016-12-15.
What interventions are being tested in trial NCT01056393?
The interventions under investigation include: ibalizumab 800mg Q2Weeks (DRUG), ibalizumab 2000mg Q4Weeks (DRUG).
Who is sponsoring clinical trial NCT01056393?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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