Lung DiseasePhase 2NCT00052052
An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing interferon-gamma 1b in people with Lung Disease and Pulmonary Fibrosis, run by InterMune at 1 site in United States.
Trial summary
Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Lung Disease, Pulmonary Fibrosis
- What is being tested?
- interferon-gamma 1b
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Male or Female
Idiopathic Pulmonary Fibrosis
20-79 years
Must have participated in the InterMune protocol GIPF-001 study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.
Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.
- Conditions
- Lung Disease, Pulmonary Fibrosis
- Being tested
- interferon-gamma 1b
- Keywords
- idiopathic pulmonary fibrosis, IPF
- Medical subject headings
- Lung Diseases, Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon-gamma 1bDrug
200 mcg, SQ, 3x per week
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2003 (estimated)
- Study startSep 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterMune
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javier Szwarcberg, MD, Study director, InterMune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052052
- Sponsor's protocol ID
- GIPF-004
- Status last verified
- Nov 2007
- First submitted
- 21 Jan 2003
- Last updated
- 6 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.
- ClinicalTrials.gov ID
- NCT00052052
- Acronym / sponsor ID
- GIPF-004
- Conditions
- Lung Disease, Pulmonary Fibrosis
- Keywords
- idiopathic pulmonary fibrosis, IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- InterMuneIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Sep 2004 (actual)
- First posted
- 23 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon-gamma 1b200 mcg, SQ, 3x per week | Drug | – |
Primary outcome
FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Szwarcberg, MD study director
InterMune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interferon-gamma 1b in people with Lung Disease and Pulmonary Fibrosis, run by InterMune at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2007.