Trial · NCT00635089
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
NCT00635089, Phase 3, Completed, Ception Therapeutics; results first posted 2017-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis. Trials, record NCT00635089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00635089
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
- NCT number
- NCT00635089
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 190 participants, actual
- Lead sponsor
- Ception Therapeutics
- Conditions
- Eosinophilic Esophagitis
- Interventions
- reslizumab
- First posted
- 2008-03-13
- Last updated
- 2017-03-23
- Results first posted
- 2017-03-23
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months) | An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events. |
| Primary | Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes \[neutrophils\], lymphocytes, eosinophils, monocytes, basophils, platelets). |
| Primary | Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose \[nonfasting\], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals). |
| Primary | Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | Low systolic blood pressure: \< 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: \> 160 and increase (↑) of 30 mm Hg from BL (age 5-12), \> 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: \< 45 and ↓ of 12 mm Hg from BL (age 5-12), \< 55 and ↓ of 12 mm Hg from BL (age 13-18), \< 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: \> 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: \< 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), \< 60 and and ↓ of 30 bpm from BL (age 13-18), \< 50 and and ↓ of 15 bpm from BL (age \> 18); high heart rate: \> 120 and ↑ of 30 bpm from BL (age 5-12), \> 100 and ↑ of 30 bpm from BL (age 13-18), \> 100 and ↑ of 15 bpm from BL (age \> 18). Low oral body temperature: \< 35.8° Celsius (age 5 to \>18); high oral body temperature: \> 38.1° C and ↑ 2° Celsius from BL (age 5-18). |
| Primary | Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | HEENT=head, eyes, ears, nose and throat. |
| Primary | Infusion Site Evaluations | Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months) | The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events. |
| Primary | Therapeutic Classification of Concomitant Medications in at Least 10% of Participants | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | Number of participants receiving therapeutic classes of concomitant medications. |
| Secondary | Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts | Baseline, Week 16 or early withdrawal (if before Week 16) | The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study. |
| Secondary | Participant's EoE Predominant Symptoms Over Time | Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months) | The data from the patient's/parent's eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant's/parent's EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week's EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed. |
| Secondary | Physician's EoE Global Assessment Over Time | Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months) | The data from the participant's/parent's EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician's EoE Global Assessment. All components of the patient's EoE Symptom Assessment were used by physicians to determine the Physician's EoE Global Assessment. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months) | Three additional participants experiences anaphylactic reactions that were upgraded to serious AEs after database lock. These 3 participants are not included in this table summary. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts | Baseline, Week 16 or early withdrawal (if before Week 16) | Participants with an assessment at Baseline and Week 16 (or early withdrawal). | eosinophils/high power field (hpf) | MEAN |
| PRIMARY | Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | Participants with a postbaseline result for hematology tests. | participants | NUMBER |
| PRIMARY | Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | participants | NUMBER | |
| PRIMARY | Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | participants | NUMBER | |
| PRIMARY | Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | participants | NUMBER | |
| PRIMARY | Infusion Site Evaluations | Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months) | Number of Participants Analyzed= all participants in study (n=190); n=number of participants graded at given time point. | participants | NUMBER |
| PRIMARY | Therapeutic Classification of Concomitant Medications in at Least 10% of Participants | From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) | participants | NUMBER | |
| SECONDARY | Participant's EoE Predominant Symptoms Over Time | Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months) | The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized. | ||
| SECONDARY | Physician's EoE Global Assessment Over Time | Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months) | The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | Open-Label Reslizumab | Any AEs | 177 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | Open-Label Reslizumab | Severe AEs | 38 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | Open-Label Reslizumab | Treatment-related AEs | 63 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | Open-Label Reslizumab | Deaths | 0 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | Open-Label Reslizumab | Other Serious AEs | 21 | participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs | Open-Label Reslizumab | Withdrawn from study due to AEs | 7 | participants | |
| Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts | Open-Label Reslizumab | -62.0 | Standard Deviation 77.97 | eosinophils/high power field (hpf) | |
| Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value | Open-Label Reslizumab | Hemoglobin </= 100 g/L | 1 | participants | |
| Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value | Open-Label Reslizumab | Hematocrit < 0.30 L/L | 1 | participants | |
| Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value | Open-Label Reslizumab | Leukocytes </= 3*10^9/L | 7 | participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-Label Reslizumab | 190 | |
| Overall Study | Completed >/= 16 Weeks of Study | Open-Label Reslizumab | 181 | |
| Overall Study | COMPLETED | Open-Label Reslizumab | 112 | |
| Overall Study | NOT COMPLETED | Open-Label Reslizumab | 78 |
Source ClinicalTrials.gov
Adverse events60
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 | Lymphadenopathy | Blood and lymphatic system disorders | Open-Label Reslizumab | 17 | 190 | 18 |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Reslizumab | 22 | 190 | 23 |
| other | Abdominal pain upper | Gastrointestinal disorders | Open-Label Reslizumab | 17 | 190 | 51 |
| other | Constipation | Gastrointestinal disorders | Open-Label Reslizumab | 17 | 190 | 20 |
| other | Diarrhoea | Gastrointestinal disorders | Open-Label Reslizumab | 25 | 190 | 38 |
| other | Nausea | Gastrointestinal disorders | Open-Label Reslizumab | 23 | 190 | 27 |
| other | Vomiting | Gastrointestinal disorders | Open-Label Reslizumab | 27 | 190 | 37 |
| other | Fatigue | General disorders | Open-Label Reslizumab | 12 | 190 | 21 |
| other | Pyrexia | General disorders | Open-Label Reslizumab | 29 | 190 | 41 |
| other | Food allergy | Immune system disorders | Open-Label Reslizumab | 15 | 190 | 16 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-Label Reslizumab | ||
| Total, other adverse events | Open-Label Reslizumab | 167 | 190 |
| Total, serious adverse events | Open-Label Reslizumab | 21 | 190 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00635089
GET https://conductscience.org/api/trials/v1/NCT00635089/results?page=2