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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

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Trial Conditions
  • Idiopathic Pulmonary Fibrosis
What is the purpose of this trial?

To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these subjects.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
40  - 80 

Gender:
Both

Eligibility

Inclusion Criteria:

1. Age 40 to 80 years, inclusive.

2. Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in
some cases by surgical lung biopsy) and reduced lung function (forced vital
capacity).

3. History of IPF of 4 years' duration or less.

4. Forced Vital Capacity (FVC) 55% to 90% of predicted value at screening.

5. Women of childbearing potential, and men, must be willing to use a medically
acceptable method of contraception during the trial and 3 months after the last dose
of study drug.

6. All subjects whose FVC percent predicted value (mean of Week 36 and Week 48 values)
shows less than 3% absolute decrease from baseline (mean of Screening Visit 1 and Day
1 values) in the Randomized Treatment Phase will be offered participation in an
Extended Treatment Phase.

Exclusion Criteria:

1. Women who are pregnant or nursing.

2. History of any other types of lung or heart disease and any other medical conditions
that, in the opinion of the investigator, would preclude the subject's participation
in the study.

3. Clinically important abnormal laboratory tests.

4. Upper or lower respiratory tract infection of any type within 4 weeks of the first
screening visit.

5. Acute exacerbation of IPF within 3 months of the first screening visit.

6. Use of certain medications and investigational drugs within 4 weeks of the first
screening visit.

7. History of cancer of any type in the 5 years preceding the first screening visit,
excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical
cancer.

8. Diffusing capacity (DLCO) less than 30% of predicted value at screening.

9. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies.

10. Previous treatment with FG-3019.

11. Body weight greater than 130 kilograms.

Gender: Both
Steward Physician(s)
  • Mark Wencel, M.D
  • Joao de Andrade, M.D
  • David Riley, M.D.
  • Peter LaCamera, M.D.
  • Danielle Antin-Ozerkis, M.D.
  • James Allen, M.D.
  • Rishi Raj, M.D.
  • Neil Ettinger, M.D
  • Rafael Perez, M.D
  • Timothy Albertson, M.D
  • Kevin DeBoer, D.O.
  • Yolanda Mageto, M.D.
  • Srihari Veeraraghavan, M.D
  • Markus Gutsche, M.D
  • Kevin Gibson, M.D
  • Lisa Lancaster, M.D.
  • Mary Scholand, M.D.
  • Jonathan Ruzi, M.D.
  • Mark Rolfe, M.D.
  • Mark Hamblin, M.D.
  • Daniel Culver, D.O.
  • John Fitzgerald, M.D.
  • John Belperio, M.D.
  • Richard Enelow, M.D.
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Drug
  • FG-3019
  • Placebo
For more information about this trial, contact

Peter LaCamera, M.D.
peter.lacamera@steward.org
Phone: (617) 789-2078


Physician Researcher

Investigator Name:

  • Mark Wencel, M.D
  • Joao de Andrade, M.D
  • David Riley, M.D.
  • Peter LaCamera, M.D.
  • Danielle Antin-Ozerkis, M.D.
  • James Allen, M.D.
  • Rishi Raj, M.D.
  • Neil Ettinger, M.D
  • Rafael Perez, M.D
  • Timothy Albertson, M.D
  • Kevin DeBoer, D.O.
  • Yolanda Mageto, M.D.
  • Srihari Veeraraghavan, M.D
  • Markus Gutsche, M.D
  • Kevin Gibson, M.D
  • Lisa Lancaster, M.D.
  • Mary Scholand, M.D.
  • Jonathan Ruzi, M.D.
  • Mark Rolfe, M.D.
  • Mark Hamblin, M.D.
  • Daniel Culver, D.O.
  • John Fitzgerald, M.D.
  • John Belperio, M.D.
  • Richard Enelow, M.D.

Other Information

Sponsor: FibroGen
Phase: Phase 2
Trial ID: NCT01890265
Volunteers:  Not Accepting Healthy Volunteers

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