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Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis (FGCL-3019-049)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01262001
First received: December 15, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
 Drug: FG-3019
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FibroGen:

Primary Outcome Measures:
  • To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-Extension) and 30 mg/kg (Cohort 2) by intravenous infusion every 3 weeks for 45 weeks in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-Extension: Up to 109 weeks, Cohort 2: Up to 58 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-Extension: Up to 109 weeks, Cohort 2: Up to 58 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-Extension: Up to 109 weeks, Cohort 2: Up to 58 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of FG-3019 on dyspnea in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-Extension: Up to 109 weeks, Cohort 2: Up to 58 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: FG-3019
    15 mg/kg (Cohort 1 and Cohort 1-Extension) and 30 mg/kg (Cohort 2) every 3 weeks for 45 weeks.
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Age 35 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 5 years' duration or less.
  4. Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the last 18 months for Cohort 2 before 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.

Main 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 within 4 weeks of the first screening visit.
  7. Receipt of an investigational drug within 6 weeks of the first screening visit.
  8. 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.
  9. Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.
  10. Planned elective surgery during the study including 4 weeks following the final dose of study drug.
  11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
  12. Inability to cooperate with study personnel or history of non-compliance to a medical regimen.
  13. Previous treatment with FG-3019.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262001

  Show 18 Study Locations
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01262001     History of Changes
Other Study ID Numbers: FGCL-3019-049
Study First Received: December 15, 2010
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 23, 2013