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Study of Interferon gamma-1b by injection for the treatment of patients with cystic fibrosis



Study of Interferon gamma-1b by injection for the treatment of patients with cystic fibrosis

For Condition: Cystic Fibrosis
Status: Terminated
Sponsor(s): InterMune ,
Synopsis: The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Years/
Genders: Both
Protocol Entry Criteria: - At least 6 years of age - Diagnosis of cystic fibrosis (against certain criteria) - Able to perform pulmonary (lung) function tests and participate in induced sputum procedures - Pulmonary function values must meet certain minimal requirements - Must have acceptable laboratory test results - Cannot be on certain medications during and immediately prior to study - Cannot have a history of unstable or deteriorating cardiac or neurologic disease
Total Enrollment: 45

Location and Contact Information:


Additional Information:
Study ID Numbers:
  GICF-002; 
Study Start Date: April 2002
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043342

Other Cystic Fibrosis Studies:
1. Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

2. Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis

3. Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis

4. Study of Interferon gamma-1b by injection for the treatment of patients with cystic fibrosis

5. Quantification of pulmonary neutrophil activity in cystic fibrosis using radiolabeled fluorodeoxyglucose and PET imaging

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