An Open-Label Study of the Safety of Interferon Gamma-1b... | NCT00076635

Studies
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

NCT00076635

Sponsor

InterMune

Status

Terminated

Last Update Posted

Nov 6, 2007Estimated

Enrollment

91Actual

Phase

Phase 3

Conditions

Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Disease

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

program discontinued based on GIPF-007 results

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Jan 28, 2004

First Submission Date that Met QC Criteria

Jan 29, 2004

First Posted Date

Jan 30, 2004Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.

Detailed Description

Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

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
All adverse events up to the end of study		3.5 years
Survival status at end of study		3.5 years
Serum antibodies to Interferon gamma-1b after the last injection.		3.5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Enrollment in Protocol GIPF 002 Part B or GIPF-004
Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
Able to understand and sign a written informed consent form and comply with the requirements of the study

Exclusion criteria:

pregnancy or lactation
lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
if Principal Investigator deems patient is unsuitable for study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
InterMune, Inc. 888-486-6411	Medical Information

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intermune Inc		Brisbane	California	94005	United States

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis
D011658	Pulmonary Fibrosis
D008171	Lung Diseases
D005355	Fibrosis

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C554125	interferon gamma-1b

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided