NCT00047658

Brief Summary

Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with corticosteroids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2002

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

November 6, 2007

Status Verified

November 1, 2007

First QC Date

October 9, 2002

Last Update Submit

November 2, 2007

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • change in percent predicted FVC, resting arterial blood gas assessment of alveolar-arterial oxygen gradient, percent predicted DLCO, dyspnea scale, baseline dyspnea index/transition dyspnea index

    23 weeks

Interventions

Interferon-gamma 1bDRUG

200 mcg, SQ, 3x per week

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Male or Female 20-79 years old

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCLA, Dept. of Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • Williamson Bradford, MD

    InterMune

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2002

First Posted

October 11, 2002

Study Start

November 1, 2001

Study Completion

May 1, 2003

Last Updated

November 6, 2007

Record last verified: 2007-11

Locations

US(1)