Clinical Trials
Since 1998, Vanderbilt has been able to offer patients diagnosed with idiopathic pulmonary fibrosis a wider variety of clinical trials from Biogen's Avonex trial to the multiple pharmaceutical trials of investigational drugs including interferon gamma-1b, imatinab mesylate, bosentan, and more. We are now able to offer patients even more as a member of the IPF Net sponsored by the National Institutes of Health (NIH).
Below is a list of the IPF trials that we have offered beginning with currently enrolling trials followed by trials that have closed. To learn more about any of these trials, please contact the Study Coordinators at 615-343-7068. If you feel that you may be a candidate for one of the Active or Upcoming trials, please submit your information as mentioned on the the Need an Evaluation page in this website.
ACTIVELY ENROLLING
ARTEMIS-IPF - This study will enroll 600 participants from around the world. We expect to enroll about 10 participants at Vanderbilt. It is a study to determine if taking ambrisentan will delay disease progression and death in those with IPF. The study is considered “event-driven” which means that it will last until a certain number of “events” occur. It is estimated that this study will last up to three years. It will involve a screening visit, which will require a right heart catheterization, and a baseline visit. On the baseline visit, the first dose of study medication will be given. Visits will continue every three months until the end of the study. At the one year mark, or the end of the study, a second right heart catheterization will be performed. Monthly, the patient will need to have safety laboratory testing completed, which can be done locally. Patients will be randomized to receive in a 2:1 fashion to received either ambrisentan or placebo. All visits (except the monthly laboratory checks) will be completed at Vanderbilt Medical Center. This study is open for enrollment.
ARTEMIS-PH - This placebo-controlled study will enroll 225 participants from around the world with 10 of these participants being enrolled at Vanderbilt. It is a study to determine if taking ambrisentan will improve 6-minute walk distance. It will also evaluate any difference in long-term survival, shortness of breath symptoms, and pulmonary function testing (PFTs). The study is only open to IPF patients who also have pulmonary hypertension (PH) (high blood pressure in the lungs), otherwise known as IPF-PH. This study will last 60 weeks. The patient will receive 48 weeks of either ambrisentan or placebo and then 8 weeks of ambrisentan. It will involve a screening visit, which will require a right heart catheterization, and a baseline visit within four weeks. On the baseline visit, the first dose of study medication will be given. Visits will continue every month for the first four months and then occur every 3 months until Week 48. At Week 48 patients will be given ambrisentan and asked to return every 4 weeks until Week 56. Monthly, patients will need to have safety laboratory testing completed, which can be done locally. Patients will be randomized to receive either ambrisentan or placebo in a 2:1 fashion. All visits (except the monthly laboratory checks) will be completed at Vanderbilt Medical Center.
UPCOMING STUDIES
(Note: There are other trials that we have been contacted about. I am unable to place those references on our web site until things are more "official"... so keep watching... there is more to come!)
CONTINUING STUDIES (NOT CURRENTLY ENROLLING)
CNTO vs. placebo - We have completed our enrollment criteria of 12 patients and have been capped (not allowed to enroll further). Patients continue to receive protocol-specific treatments and procedures. Other IPF centers across the country are continuing to enroll patients into this exciting trial. Please click on www.clinicaltrials.gov and find this study to learn of the other IPF Centers who are enrolling.
ReCAP PIPF-012 - pirfenidone - This study was only made available to those patients who participated in the CAPACITY trial. These patients will continue to be followed on pirfenidone until the FDA reviews and approves/denies the drug for use to treat IPF. Please go to www.intermune.com to keep updated with the status of pirfenidone.
BUILD-3 - bosentan vs. placebo - Patients were randomized to recieve either bosentan or placebo until a pre-determined number of events occur. An event is a death or a worsening in pulmonary function defined by the protocol. 400 patients from around the world have been enrolled in this study, with 19 patients enrolled at Vanderbilt.
BUILD-1 - bosentan vs. placebo - Patients who have chosen to continue into the open-label portion of this study are currently recieving bosentan. The placebo-controlled portion of the study is now finished and results are available on-line at www.actelion.com under Media Releases, November 2005. These patients will continue to be followed on bosentan. The findings of this study generated BUILD-3.
COMPLETED and CLOSED STUDIES
NIH, IPFNET STEP -
CAPACITY (PIPF-006) - 27 patients enrolled at Vanderbilt
GC1008 (Phase 1) - 3 patients enrolled at Vanderbilt
Inhaled Iloprost vs. Placebo - 7 patients enrolled at Vanderbilt
Gleevec vs. Placebo - 6 patients enrolled at Vanderbilt
GIPF-007 - interferon gamma-1b - 27 patients enrolled at Vanderbilt
GIPF-006 - interferon gamma-1b - 5 patients enrolled at Vanderbilt
GIPF-004 - interferon gamma-1b - 9 patients enrolled at Vanderbilt.
GIPF-002 - interferon gamma-1b vs. placebo - 2 patients enrolled at Vanderbilt.
GIPF-001 - interferon gamma-1b vs. placebo -10 patients enrolled at Vanderbilt.
Enbrel vs. Placebo - 5 patients enrolled at Vanderbilt.
Avonex vs. Placebo - 8 patients enrolled at Vanderbilt.
