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Idiopathic Pulmonary Fibrosis (IPF)

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Rainier: A Phase 2, Randomized, Double-blind, Placebo Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects with Idiopathic Pulmonary Fibrosis.

This is a multi-center, randomized, double-blind, placebo controlled study for Simtuzumab (GS-6624) by Rainier to assess the efficacy of study treatment for IPF patients. The study will last up to 3.5 years. Throughout the study you will take the study drug, either the investigation drug or placebo, as a once weekly injection. The purpose is to evaluate if the investigational drug may slow the progression of IPF disease.

Principal Investigator: Ibrahim Faruqi, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01769196?term=RAINIER&rank=2

For more information, please contact Jesse West, RN at 352-273-8666.

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Stromedix: Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This is a multi-center, randomized, double-blind, placebo-controlled, multiple dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact on BAL and peripheral blood biomarkers of STX-100 in patients with IPF. Approximately 32 patients will be enrolled into 4 sequential ascending dose cohorts. Each cohort will include 8 patients randomized to receive either STX-100 (6 patients) or placebo (2 patients). Additional patients may be enrolled if deemed appropriate by the Data Safety Monitoring Board (DSMB).

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01371305?term=Stromedix&rank=2

For more information, please contact Joanna Nolte, ARNP at 352-273-7225.

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BMS: Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis

The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/study/NCT01766817?term=BMS+IPF&rank=1&show_locs=Y#locn

For more information, please contact Brooks Morgan, RN at 352-273-5870.

Closed

InterMune: A Treatment Protocol to Allow Patients in the US with Idiopathic Pulmonary Fibrosis Access to Pirfenidone

 The purpose of this study is to provide individuals who meet study inclusion criteria early access to pirfenidone.

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://www.clinicaltrials.gov/ct2/show/NCT02141087?term=InterMune&rank=20

For more information, please contact Jesse West, RN at 352-273-8666.

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InterMune: Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PIPF-012)

This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.

Principal Investigator: Mark Brantly, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT00662038?term=PIPF-012&rank=1

For more information, please contact Jesse West, RN at 352-273-8666.

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ASCEND: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.

The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/results?term=IPF&pg=2

For more information, please contact Jesse West, RN at 352-273-8666.

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QAX576: A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF

This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.

Principal Investigator: Ibrahim Faruqi, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01266135

For more information, please contact Jesse West, RN at 352-273-8666.