Trial · NCT00927953
Treatment of West Nile Virus With MGAWN1
NCT00927953, Phase 2, Terminated, MacroGenics; results first posted 2012-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of West Nile Virus With MGAWN1. Trials, record NCT00927953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00927953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of West Nile Virus With MGAWN1
- NCT number
- NCT00927953
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- MacroGenics
- Conditions
- West Nile Neuroinvasive Disease, West Nile Virus Infection, Encephalitis, Meningitis, Acute Flaccid Paralysis, West Nile Fever
- Interventions
- MGAWN1, Placebo - normal saline
- First posted
- 2009-06-25
- Last updated
- 2022-02-10
- Results first posted
- 2012-11-07
- Limitations and caveats
- Early termination due to the inability to enroll (only 13 of 120 subjects enrolled); leading to small numbers of subjects analyzed and therefore many pre-specified analyses were not performed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | Study Day 2, 7, 14, 28, and 120 | The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead |
| Primary | The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event | 120 days | Includes adverse events considered possibly, probably, or definitely related to study drug |
| Secondary | The Number of Participants With a Favorable Neurologic Outcome | Study Day 2, 7, 14, 28, and 120 | Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is \<=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead. |
| Secondary | Mean Modified Rankin Scale Scores | Study Day 0, 2, 7, 14, 28, and 120 | The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead. |
| Secondary | Time to a >= 1 Point Reduction in the Modified Rankin Scale Score | Study Day 2, 7, 14, 28, and 120 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | Study Day 2, 7, 14, 28, and 120 | All randomized participants with confirmed West Nile virus infection | participants | NUMBER |
| PRIMARY | The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event | 120 days | Intention to treat (ITT) | participants | NUMBER |
| SECONDARY | The Number of Participants With a Favorable Neurologic Outcome | Study Day 2, 7, 14, 28, and 120 | participants | NUMBER | |
| SECONDARY | Mean Modified Rankin Scale Scores | Study Day 0, 2, 7, 14, 28, and 120 | units on a scale | MEAN | |
| SECONDARY | Time to a >= 1 Point Reduction in the Modified Rankin Scale Score | Study Day 2, 7, 14, 28, and 120 | Intention to treat (ITT) | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | MGAWN1 | Day 2 | 0 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | Placebo-Normal Saline | Day 2 | 2 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | MGAWN1 | Day 7 | 1 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | Placebo-Normal Saline | Day 7 | 3 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | MGAWN1 | Day 14 | 2 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | Placebo-Normal Saline | Day 14 | 3 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | MGAWN1 | Day 28 | 2 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | Placebo-Normal Saline | Day 28 | 4 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | MGAWN1 | Day 120 | 2 | participants | |
| The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) | Placebo-Normal Saline | Day 120 | 3 | participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MGAWN1 | 6 | |
| Overall Study | STARTED | Placebo - Normal Saline | 7 | |
| Overall Study | COMPLETED | MGAWN1 | 4 | |
| Overall Study | COMPLETED | Placebo - Normal Saline | 6 | |
| Overall Study | NOT COMPLETED | MGAWN1 | 2 | |
| Overall Study | NOT COMPLETED | Placebo - Normal Saline | 1 |
Source ClinicalTrials.gov
Adverse events106
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Activated PTT prolonged | Investigations | MGAWN1 | 0 | 6 | 0 |
| other | Activated PTT prolonged | Investigations | Placebo - Normal Saline | 1 | 7 | 1 |
| other | Alanine aminotransferase increased | Investigations | MGAWN1 | 0 | 6 | 0 |
| other | Alanine aminotransferase increased | Investigations | Placebo - Normal Saline | 3 | 7 | 3 |
| other | Anxiety | Psychiatric disorders | MGAWN1 | 1 | 6 | 1 |
| other | Anxiety | Psychiatric disorders | Placebo - Normal Saline | 0 | 7 | 0 |
| other | Aspartate aminotransferase increased | Investigations | MGAWN1 | 0 | 6 | 0 |
| other | Aspartate aminotransferase increased | Investigations | Placebo - Normal Saline | 2 | 7 | 2 |
| other | Ataxia | Nervous system disorders | MGAWN1 | 1 | 6 | 1 |
| other | Ataxia | Nervous system disorders | Placebo - Normal Saline | 0 | 7 | 0 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MGAWN1 | ||
| Total, all-cause mortality | Placebo - Normal Saline | ||
| Total, other adverse events | MGAWN1 | 5 | 6 |
| Total, other adverse events | Placebo - Normal Saline | 7 | 7 |
| Total, serious adverse events | MGAWN1 | 3 | 6 |
| Total, serious adverse events | Placebo - Normal Saline | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MGAWN1 vs Placebo - Normal Saline: The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event | Trial comparisons |
| MGAWN1 vs Placebo - Normal Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00927953
GET https://conductscience.org/api/trials/v1/NCT00927953/results?page=2