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NCT00784147 · ClinicalTrials.gov registry record · Phase 2
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
A Phase 2 study, sponsored by TaiMed Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT00784147 is a Phase 2 study that has completed, run by TaiMed Biologics. The registered enrollment target is 113 participants.
The verdict
NCT00784147, a Phase 2 study, has completed, sponsored by TaiMed Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study Summary
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV).
Interventions
- DRUG Ibalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00784147
The ClinicalTrials.gov registry entry for NCT00784147 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TaiMed Biologics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ibalizumab is the first listed.
NCT00784147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00784147 about?
NCT00784147 is a clinical study titled "Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1". The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen ...
What is the current status of trial NCT00784147?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2008-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00784147?
The interventions under investigation include: Ibalizumab (DRUG).
Who is sponsoring clinical trial NCT00784147?
This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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