Idiopathic Pulmonary FibrosisPhase 3NCT00076635
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
A Phase 3 study testing Interferon gamma-1b in people with Idiopathic Pulmonary Fibrosis and Pulmonary Fibrosis, run by InterMune at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Disease
- What is being tested?
- Interferon gamma-1b
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Apr 2007
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis
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.
Read the 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.
- Being tested
- Interferon gamma-1b
- Keywords
- Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Actimmune, Interferon, Gamma, InterMune
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Diseases, 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.
All adverse events up to the end of study
Measured: 3.5 years
Survival status at end of study
Measured: 3.5 years
Serum antibodies to Interferon gamma-1b after the last injection.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2004 (estimated)
- Study startNov 2003
- Study completionApr 2007
Why it stopped: program discontinued based on GIPF-007 results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterMune
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- InterMune, Inc. 888-486-6411, Medical Information
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076635
- Sponsor's protocol ID
- GIPF-006
- Status last verified
- Nov 2007
- First submitted
- 28 Jan 2004
- Last updated
- 6 Nov 2007
- Results posted
- No
- Data monitoring committee
- 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 of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00076635
- Acronym / sponsor ID
- GIPF-006
- Keywords
- Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Actimmune, Interferon, Gamma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: program discontinued based on GIPF-007 results
- Enrolment
- 91 participants (actual)
- Lead sponsor
- InterMuneIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Apr 2007 (actual)
- First posted
- 30 Jan 2004 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
All adverse events up to the end of study
Time frame: 3.5 years
Survival status at end of study
Time frame: 3.5 years
Serum antibodies to Interferon gamma-1b after the last injection.
Time frame: 3.5 years
Results and safety
The study was stopped early (reason given: program discontinued based on GIPF-007 results). Results are not available in the source record.
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.
InterMune, Inc. 888-486-6411
Medical Information
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon gamma-1b in people with Idiopathic Pulmonary Fibrosis 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: stopped early, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: program discontinued based on GIPF-007 results). Results are not available in the source record.
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?
All adverse events up to the end of study (time frame: 3.5 years). The study lists 3 primary outcomes in all. 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.