Hypereosinophilic SyndromesPhase 1/2NCT00266565
Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome
A Phase 1/2 study testing Mepolizumab in people with Hypereosinophilic Syndromes and Eosinophilic Gastroenteritis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Toxicity of anti-IL-5 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypereosinophilic Syndromes, Eosinophilic Gastroenteritis, Churg-Strauss Syndrome
- What is being tested?
- Mepolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Apr 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adequate renal, cardiac, and hepatic function
- Not pregnant or breastfeeding
- A diagnosis of hypereosinophilic syndrome such as:
- Idiopathic hypereosinophilic syndrome;
- Eosinophilia myalgia syndrome;
- Eosinophilic gastroenteritis;
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- Churg-Strauss syndrome;
- Eosinophilic cellulitis;
- Benign hypereosinophilia; or
- Eosinophilic esophagitis.
- Maintained on, or in need of, the following: glucocorticoids, interferon, methotrexate, hydroxyurea, cytoxan, 6-mercaptopurine, or vincristine
- Blood eosinophil counts greater than 750 cells/mcl
Who cannot join
- Creatinine > 3 X upper limit for age
- AST > 5 X upper limit for age
- Platelet count < 50,000/mm3
- Cardiac function:
- NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);
- Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;
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- Patients requiring IV heart failure medications;
- Angina or acute myocardial infarction
- History of renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results
- History of allergic or adverse response to previous antibody type therapy
- History of allergic or adverse response to anti-IL-5 therapy
- Evidence of, or history of, a parasitic infection (within past 1 year)
- Participation in a previous clinical trial involving an investigational agent within 30 days prior to study initiation
- Receipt of anti-IL-5 therapy in the past
- Blood donation of 450 ml (1 pint) or more within 30 days prior to study initiation
- Abnormal or unusual diet or substantial changes in eating habits within 30 days prior to, or during, the study.
- Patients who do not have eosinophil levels > 750 cells/mcl after the run-in period. Patients who have only eosinophilic infiltration of tissue are eligible if they do not develop an eosinophil level > 750 cells/mcl, assuming that they meet all other eligibility requirements.
- Positive serum pregnancy test
- Breastfeeding
- Unable to use effective birth control methods for duration of study
- Unable or unwilling to give voluntary informed consent/assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes
Toxicity of anti-IL-5
Read the detailed description
The purpose of the study is to assess the toxicity of anti-IL-5, and to see whether it lowers peripheral blood eosinophils and/or tissue and whether it has a steroid and/or interferon sparing effect.
- Conditions
- Hypereosinophilic Syndromes, Eosinophilic Gastroenteritis, Churg-Strauss Syndrome, Eosinophilic Esophagitis
- Being tested
- Mepolizumab
- Medical subject headings
- Hypereosinophilic Syndrome, Eosinophilic enteropathy, Churg-Strauss Syndrome, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Also called Anti-IL5
10mg/kg (max 750 ml) once a month for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Anti-IL5 (Mepolizumab) | Experimental | The purpose of the study is to assess the toxicity of anti-IL-5 (Mepolizumab), and to see whether it lowers eosinophils in peripheral blood and/or tissue and whether it has a steroid and/or interferon sparing effect. Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the toxicity of anti-IL-5 in patients with hypereosinophilia
Measured: 28 weeks
Secondary outcomes (2)
To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia
Measured: 28 weeks
To assess whether anti-IL-5 has a steroid and/or interferon sparing effect
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startDec 2001
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypereosinophilic SyndromesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc E. Rothenberg, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266565
- Sponsor's protocol ID
- 01-9-18
- Other IDs
- FD-R-002396
- Status last verified
- Jul 2020
- First submitted
- 15 Dec 2005
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes
- ClinicalTrials.gov ID
- NCT00266565
- Acronym / sponsor ID
- 01-9-18
- Conditions
- Hypereosinophilic Syndromes, Eosinophilic Gastroenteritis, Churg-Strauss Syndrome, Eosinophilic Esophagitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Dec 2001 (actual)
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 19 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Toxicity of anti-IL-5
Detailed description
The purpose of the study is to assess the toxicity of anti-IL-5, and to see whether it lowers peripheral blood eosinophils and/or tissue and whether it has a steroid and/or interferon sparing effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-IL5 (Mepolizumab) | Experimental | Drug: MepolizumabThe purpose of the study is to assess the toxicity of anti-IL-5 (Mepolizumab), and to see whether it lowers eosinophils in peripheral blood and/or tissue and whether it has a steroid and/or interferon sparing effect. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adequate renal, cardiac, and hepatic function
- Not pregnant or breastfeeding
- A diagnosis of hypereosinophilic syndrome such as:
- Maintained on, or in need of, the following: glucocorticoids, interferon, methotrexate, hydroxyurea, cytoxan, 6-mercaptopurine, or vincristine
- Blood eosinophil counts greater than 750 cells/mcl
Key exclusion criteria (21 listed)
- Creatinine > 3 X upper limit for age
- AST > 5 X upper limit for age
- Platelet count < 50,000/mm3
- Cardiac function:
- History of renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MepolizumabAlso: Anti-IL510mg/kg (max 750 ml) once a month for 3 months | Drug | Anti-IL5 (Mepolizumab) |
Primary outcome
To assess the toxicity of anti-IL-5 in patients with hypereosinophilia
Time frame: 28 weeks
2 secondary outcomes
To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia
Time frame: 28 weeks
To assess whether anti-IL-5 has a steroid and/or interferon sparing effect
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc E. Rothenberg, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mepolizumab in people with Hypereosinophilic Syndromes and Eosinophilic Gastroenteritis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the toxicity of anti-IL-5 in patients with hypereosinophilia (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.