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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01262001
First received: December 15, 2010
Last updated: August 3, 2017
Last verified: August 2017
History of Changes
December 15, 2010
August 3, 2017
March 2011
June 26, 2014   (Final data collection date for primary outcome measure)
To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
To determine the safety and tolerability of FG-3019 administered at a dose of 15 mg/kg by intravenous infusion every 3 weeks for 45 weeks in subjects with IPF. [ Time Frame: Up to 60 weeks total ]
Complete list of historical versions of study NCT01262001 on ClinicalTrials.gov Archive Site
  • 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-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
  • To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
  • To evaluate the effect of FG-3019 on dyspnea in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
  • To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF. [ Time Frame: 48 weeks ]
  • To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF. [ Time Frame: 48 weeks ]
  • To evaluate the effect of FG-3019 on dyspnea in subjects with IPF. [ Time Frame: 48 weeks ]
Not Provided
Not Provided
 
Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
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.
Major Changes: FGCL-3019-049 Protocol Amendment 3 offers long-term extension of treatment with FG-3019 to eligible Cohort 1-EX (approximately 14 subjects) and Cohort 2 (approximately 28 subjects) subjects who complete the Week 48-EX and Week 48 assessments described in Protocol Amendment 2, respectively. A subject is eligible for long-term extension of treatment if the investigator, after discussion with the Fibrogen Medical Monitor, believes that the subject would benefit from continued treatment with FG-3019.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
Drug: FG-3019
15 mg/kg (Cohort 1 and Cohort 1-Extension) and 30 mg/kg (Cohort 2 and Cohort 2-EX) by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years..
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 21, 2017
June 26, 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01262001
FGCL-3019-049
No
Not Provided
Not Provided
FibroGen
FibroGen
Not Provided
Not Provided
FibroGen
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP