Trial · NCT00538785
A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
NCT00538785, Phase 2, Completed, MedImmune LLC; results first posted 2012-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease. Trials, record NCT00538785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00538785
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
- NCT number
- NCT00538785
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,236 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Congenital Heart Disease
- Interventions
- Motavizumab, Palivizumab
- First posted
- 2007-10-03
- Last updated
- 2012-02-16
- Results first posted
- 2012-02-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Adverse Events Through Study Day 150 | Days 0-150 | Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall. |
| Primary | Number of Subjects Reporting Serious Adverse Events Through Study Day 150 | Days 0-150 | Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. |
| Primary | Number of Subjects Reporting Laboratory Adverse Events | Days 0-150 | |
| Secondary | The Number of Subjects Hospitalized for RSV Infection. | Days 0-150 | An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy). |
| Secondary | The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only. | Days 0-150 | An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory. |
| Secondary | Number of Subjects Who Had Anti-motavizumab Antibodies Detected | Days 0-150 | ECLA-based method |
| Secondary | Mean Trough Serum Concentration of Motavizumab at Pre-dose 1 | Pre-dose 1 | Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1 |
| Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1 | 30 days post-dose 1 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1 |
| Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2 | 30 days post-dose 2 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2 |
| Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3 | 30 days post-dose 3 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting Adverse Events Through Study Day 150 | Days 0-150 | The Safety population included all subjects who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Subjects Reporting Serious Adverse Events Through Study Day 150 | Days 0-150 | The Safety population included all subjects who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Subjects Reporting Laboratory Adverse Events | Days 0-150 | Safety population | participants | NUMBER |
| SECONDARY | The Number of Subjects Hospitalized for RSV Infection. | Days 0-150 | The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study. | participants | NUMBER |
| SECONDARY | The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only. | Days 0-150 | All subjects who were randomized in Season 2 | participant | NUMBER |
| SECONDARY | Number of Subjects Who Had Anti-motavizumab Antibodies Detected | Days 0-150 | Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug. | participants | NUMBER |
| SECONDARY | Mean Trough Serum Concentration of Motavizumab at Pre-dose 1 | Pre-dose 1 | Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery. | ug/mL | MEAN |
| SECONDARY | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1 | 30 days post-dose 1 | Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery. | ug/mL | MEAN |
| SECONDARY | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2 | 30 days post-dose 2 | Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery. | ug/mL | MEAN |
| SECONDARY | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3 | 30 days post-dose 3 | Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery. | ug/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting Adverse Events Through Study Day 150 | Motavizumab (MEDI-524) | 575 | participants | ||
| Number of Subjects Reporting Adverse Events Through Study Day 150 | Palivizumab | 566 | participants | ||
| Number of Subjects Reporting Serious Adverse Events Through Study Day 150 | Motavizumab (MEDI-524) | 292 | participants | ||
| Number of Subjects Reporting Serious Adverse Events Through Study Day 150 | Palivizumab | 304 | participants | ||
| Number of Subjects Reporting Laboratory Adverse Events | Motavizumab (MEDI-524) | Adrenal insufficiency | 3 | participants | |
| Number of Subjects Reporting Laboratory Adverse Events | Palivizumab | Adrenal insufficiency | 3 | participants | |
| Number of Subjects Reporting Laboratory Adverse Events | Motavizumab (MEDI-524) | Alanine aminotranferase increased | 13 | participants | |
| Number of Subjects Reporting Laboratory Adverse Events | Palivizumab | Alanine aminotranferase increased | 26 | participants | |
| Number of Subjects Reporting Laboratory Adverse Events | Motavizumab (MEDI-524) | Anemia | 17 | participants | |
| Number of Subjects Reporting Laboratory Adverse Events | Palivizumab | Anemia | 14 | participants |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Motavizumab (MEDI-524) | 623 | |
| Overall Study | STARTED | Palivizumab | 612 | |
| Overall Study | COMPLETED | Motavizumab (MEDI-524) | 604 | |
| Overall Study | COMPLETED | Palivizumab | 595 | |
| Overall Study | NOT COMPLETED | Motavizumab (MEDI-524) | 19 | |
| Overall Study | NOT COMPLETED | Palivizumab | 17 |
Source ClinicalTrials.gov
Adverse events646
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 | ANAEMIA | Blood and lymphatic system disorders | Motavizumab (MEDI-524) | 14 | 618 | 15 |
| other | ANAEMIA | Blood and lymphatic system disorders | Palivizumab | 16 | 612 | 22 |
| other | CARDIAC FAILURE | Cardiac disorders | Motavizumab (MEDI-524) | 9 | 618 | 10 |
| other | CARDIAC FAILURE | Cardiac disorders | Palivizumab | 10 | 612 | 10 |
| other | CYANOSIS | Cardiac disorders | Motavizumab (MEDI-524) | 25 | 618 | 42 |
| other | CYANOSIS | Cardiac disorders | Palivizumab | 25 | 612 | 32 |
| other | CONJUNCTIVITIS | Eye disorders | Motavizumab (MEDI-524) | 39 | 618 | 42 |
| other | CONJUNCTIVITIS | Eye disorders | Palivizumab | 27 | 612 | 32 |
| other | CONSTIPATION | Gastrointestinal disorders | Motavizumab (MEDI-524) | 44 | 618 | 47 |
| other | CONSTIPATION | Gastrointestinal disorders | Palivizumab | 31 | 612 | 35 |
1 to 10 of 646Source ClinicalTrials.gov
See all 646 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Motavizumab (MEDI-524) | ||
| Total, all-cause mortality | Palivizumab | ||
| Total, other adverse events | Motavizumab (MEDI-524) | 553 | 618 |
| Total, other adverse events | Palivizumab | 540 | 612 |
| Total, serious adverse events | Motavizumab (MEDI-524) | 292 | 618 |
| Total, serious adverse events | Palivizumab | 304 | 612 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Motavizumab (MEDI-524) vs Palivizumab: Number of Subjects Reporting Adverse Events Through Study Day 150 | Trial comparisons |
| Motavizumab (MEDI-524) vs Palivizumab: The Number of Subjects Hospitalized for RSV Infection. | Trial comparisons |
| Motavizumab (MEDI-524) vs Palivizumab: Number of Subjects Reporting Serious Adverse Events Through Study Day 150 | Trial comparisons |
| Motavizumab (MEDI-524) vs Palivizumab: 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/NCT00538785
GET https://conductscience.org/api/trials/v1/NCT00538785/results?page=2