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A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood

NCT00001317 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-03-04

No results posted yet for this study

Summary

In a recent double-blinded, placebo-controlled multi-center international study, subcutaneous injections of interferon-gamma administered three times weekly reduced the frequency of serious infections in patients with chronic granulomatous disease. Patients receiving interferon-gamma had fewer hospital stays, shorter in length, than the placebo group. Children less than 10 years of age benefitted most from treatment and had fewer side effects.

Based on these data, the FDA licensed interferon-gamma for prophylaxis in CGD patients. We wish to monitor our patients who participated in the original study for possible long-term side effects. Any new patients referred to us who are either on interferon-gamma or considered to be candidates for interferon-gamma will be considered for this protocol. In addition, our patients who were originally accepted under Genentech's compassionate plea protocol will also be monitored under this new protocol. The patients will be evaluated every six months, with blood work and interim medical histories taken.

Conditions

  • Chronic Granulomatous Disease

Interventions

DRUG

interferon-gamma

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1992-05-31
Completion
2001-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001317 on ClinicalTrials.gov