Common Variable ImmunodeficiencyNCT00004695
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
A study testing PEG-interleukin-2 in people with Common Variable Immunodeficiency, run by Icahn School of Medicine at Mount Sinai.
Trial summary
OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Common Variable Immunodeficiency
- What is being tested?
- PEG-interleukin-2
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 1997to Mar 2000
- Phase
- Interventional
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations
In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures
--Prior/Concurrent Therapy--
No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day)
Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required
--Patient Characteristics--
Life expectancy: At least 24 months
Other: Not pregnant or nursing HIV negative
About this study
OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency.
II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo.
Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months.
Patients are followed every 4 months for 2 years.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Common Variable Immunodeficiency
- Being tested
- PEG-interleukin-2
- Keywords
- common variable immunodeficiency, immunologic disorders and infectious disorders, primary immunodeficiency disease, rare disease
- Medical subject headings
- Common Variable Immunodeficiency, Immune System Diseases, Communicable Diseases, Primary Immunodeficiency Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-interleukin-2Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startSep 1997
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Variable ImmunodeficiencyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Charlotte Cunningham-Rundles, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004695
- Sponsor's protocol ID
- 199/13358
- Other IDs
- MTS-93-726-ME, MTS-FDR001162
- Status last verified
- May 1999
- First submitted
- 24 Feb 2000
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
- ClinicalTrials.gov ID
- NCT00004695
- Acronym / sponsor ID
- 199/13358
- Conditions
- Common Variable Immunodeficiency
- Keywords
- common variable immunodeficiency, immunologic disorders and infectious disorders, primary immunodeficiency disease, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 1997
- Study completion
- Mar 2000
- First posted
- 25 Feb 2000 (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.
OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency.
II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
Detailed description
PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo.
Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months.
Patients are followed every 4 months for 2 years.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| PEG-interleukin-2 | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Mar 2015.
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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.
Charlotte Cunningham-Rundles study chair
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A study testing PEG-interleukin-2 in people with Common Variable Immunodeficiency, run by Icahn School of Medicine at Mount Sinai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 25 Mar 2015.