Study for Common Variable Immunodeficiency (CVID) Enteropathy

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New Study for Common Variable Immunodeficiency (CVID) Enteropathy
Credit: NIAID

If you have been diagnosed with CVID, you may be eligible to volunteer for a new research study at the National Institutes of Health (NIH).

This study evaluates the safety and effectiveness of the drug ustekinumab for people with common variable immunodeficiency (CVID) with gastrointestinal inflammation. Ustekinumab is currently approved by the Food and Drug Administration (FDA) to treat other autoimmune disorders.

Who can participate?

You may be eligible if you

  • Are 18 to 75 years old
  • Have been diagnosed with CVID
  • Have unintended weight loss over the past year, require ongoing nutritional supplements to maintain weight, or have chronic diarrhea
  • Do not have a current infection requiring antibiotics
  • Do not have HIV, hepatitis B, or hepatitis C

What does the study involve?

Volunteers will receive a single injection of the study drug at the first treatment visit. Volunteers will then attend study visits 3 weeks, 6 weeks, 3 months, and 6 months after receiving the injection. Volunteers will also undergo tests to see how immune cells and bacteria in the body react to the study drug.

Where is the study taking place?

The study is being conducted at the NIH Clinical Center in Bethesda, Maryland. The NIH campus is accessible by car and public transportation. Transportation and other expenses may be covered for eligible participants.

How much does it cost?

There is no charge to participate in this research study. All study-related medical care, including clinic visits and procedures, are provided free of charge.

Will I receive payment of some kind?

There is no compensation for participating in this study.

How do I find out more or volunteer?

To learn more about this study of the safety, tolerability, and efficacy of ustekinumab for symptomatic gastrointestinal inflammation associated with common variable immunodeficiency (trial ID: NCT02199496), visit ClinicalTrials.gov.

Content last reviewed on May 29, 2015