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NCT00043342 Clinical Trial

Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:
A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00043342
Other study ID # GICF-002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 7, 2002
Last updated October 29, 2007
Start date April 2002
Est. completion date March 2003

Study information
Verified date October 2007
Source InterMune
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date March 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility - 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• interferon gamma-1b
100 or 200 mcg, SQ, 3x per week

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
InterMune

Outcome
Type Measure Description Time frame Safety issue
Primary change in sputum neutrophil count 4 weeks
Secondary change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8 4 weeks
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