Expired Study
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Wilmington, Delaware 19803


Purpose:

This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-5-0002. The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.


Study summary:

Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002. The end of study visit for Res-5-0002 will serve as the screening visit for this trial. All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.


Criteria:

Inclusion Criteria: - Informed consent - Received at least two doses of study drug in Study 5-0002 - Did not withdraw from Study 5-0002 due to drug related AE - Completed End of Treatment Visit for Study 5-0002 Exclusion Criteria: - Pregnant or nursing females - Concurrent Immunodeficiency - Current use of immunosuppressive drugs - Did not tolerate study drug in Study 5-0002


Study is Available At:


Original ID:

Res-5-0004


NCT ID:

NCT00635089


Secondary ID:


Study Acronym:


Brief Title:

Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis


Official Title:

An Open-Label Safety and Efficacy Study of Reslizumab (CTx55700) for the Treatment of Pediatric Subjects With Eosinophilic Esophagitis Who Completed Study Res-5-0002


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

5 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Teva Pharmaceutical Industries


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

190


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sponsor's Medical Expert, MD
Study Director
Cephalon

Study Dates

Start Date:May 2008
Completion Date:January 2012
Completion Type:Actual
Primary Completion Date:January 2012
Primary Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 20, 2012
First Received Date:March 6, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:profile of durability of response to treatment
Time Frame:approximately 4 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety profile of reslizumab
Time Frame:approximately 4 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:reslizumab
Description:initial dosing of reslizumab 1mg/kg i.v.monthly
Arm Name:Open-Label
Other Name:Cinquil

Study Arms

Study Arm Type:Other
Arm Name:Open-Label
Description:Open-label active cohort

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ception Therapeutics
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Cephalon

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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