A Study of the Safety and Clinical Effects of Interferon... | NCT00047658

Studies
A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT00047658

Sponsor

InterMune

Status

Completed

Last Update Posted

Nov 6, 2007Estimated

Enrollment

32Actual

Phase

Phase 2

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Interferon-gamma 1b

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Not provided

Completion Date

May 2003Actual

First Submitted Date

Oct 9, 2002

First Submission Date that Met QC Criteria

Oct 10, 2002

First Posted Date

Oct 11, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2007

Last Update Posted Date

Nov 6, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Name	Type	Description	Arm Group Labels	Other Names
Interferon-gamma 1b	Drug	200 mcg, SQ, 3x per week

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Male or Female 20-79 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Williamson Bradford, MD	InterMune	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA, Dept. of Medicine		Los Angeles	California	90095	United States

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007371	Interferon-gamma

Ancestor Terms

ID	Term
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided