Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004695
Other study ID # 199/13358
Secondary ID MTS-93-726-MEMTS
Status Completed
Phase N/A
First received February 24, 2000
Last updated March 24, 2015
Start date September 1997
Est. completion date March 2000

Study information

Verified date May 1999
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
PEG-interleukin-2


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai
See also
  Status Clinical Trial Phase
Recruiting NCT03663933 - Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation Phase 2
Recruiting NCT01652092 - Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies N/A
Recruiting NCT05321407 - COVID-19 Vaccine Responses in PIDD Subjects
Recruiting NCT04339777 - Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity Phase 2
Completed NCT00542997 - Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy Phase 3
Completed NCT00168012 - Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID) Phase 3
Completed NCT00168025 - Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID) Phase 3
Completed NCT01196702 - Lymphocyte Immunophenotyping in Common Variable Immunodeficiency
Recruiting NCT06355323 - Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France N/A
Completed NCT00322556 - Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID) Phase 3
Recruiting NCT02579967 - Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies Phase 2
Recruiting NCT06145100 - Prediction of Portal Hypertension in Patients With CVID (CVID-pHT)
Completed NCT01289847 - A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency Phase 4
Completed NCT00520494 - Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency Phase 4
Terminated NCT00006054 - Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies N/A
Completed NCT03211689 - The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease N/A
Terminated NCT01489618 - "Prime Boost" Vaccination Strategy Combining Conjugated Anti- Pneumococcal Vaccine (s0) and Polysaccharide Anti- Pneumococcal Vaccine (s4) Compared to Polysaccharide Anti- Pneumococcal Vaccine Alone (s4) In Patients With Common Variable Immunodeficiency Phase 2
Completed NCT03513328 - Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation Phase 1/Phase 2
Completed NCT03188419 - Breadth of Donor Options for People With Inherited Diseases Requiring Allogeneic Hematopoietic Stem Cell Transplant in the Era of Alternative Donor Transplants Using Post-Transplantation Cyclophosphamide
Not yet recruiting NCT05481554 - Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency