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OpenTrials
Completed

NCT Number: NCT00001318

Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma

This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

About this study

This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Demonstrated non-tuberculous mycobacterial infection, either disseminated or pulmonary.

Received medical treatment for at least 3 months without improvement.

Preserved renal, hepatic and hematologic function.

Negative pregnancy urine and effective contraceptive.

Age range greater than 5.

No secondary immunodeficiency such as HIV or malignancy.

Not currently receiving cytotoxic therapy within the past 3 months.

Not pregnant or lactating.

No seizure disorders.

No known symptomatic cardiac disease.

Treatment and study plan

Interferon Gamma

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Important dates

Study start
1992
Study completion
2000
First posted
Dec 10, 2002
Registry last updated
Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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