Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00451321 · ClinicalTrials.gov registry record · Phase 2
TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT00451321: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT00451321 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00451321, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study Summary
The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.
Primary Outcome
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a con
Interventions
- DRUG Otelixizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2006-07-31 |
| Est. Completion | 2011-12-01 |
| Phase | Phase 2 |
Why NCT00451321 stopped before completion
NCT00451321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 1 intervention - of which Otelixizumab is the first listed.
NCT00451321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00451321 about?
NCT00451321 is a clinical study titled "TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)". The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters...
What is the current status of trial NCT00451321?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2006-07-31. Estimated completion is 2011-12-01.
What interventions are being tested in trial NCT00451321?
The interventions under investigation include: Otelixizumab (DRUG).
Who is sponsoring clinical trial NCT00451321?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00451321's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03843463 · 88 participants · Phase 2
Escitalopram and Language Intervention for Subacute Aphasia
- NCT04066348 · 88 participants · Phase 2
TNF-α Treatment of Blast-Induced Tinnitus
- NCT04331704 · 88 participants · Phase 4
ANCHORS Alcohol & Sexual Health Study: UH3 Project
- NCT04536103 · 88 participants
Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI