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Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125385
First Posted: August 1, 2005
Last Update Posted: April 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose
This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Biological: GC1008 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF [ Time Frame: up to 3 years ]

Secondary Outcome Measures:
  • To evaluate potential clinical outcomes and bioactivity of GC1008 [ Time Frame: up to 3 years ]

Enrollment: 25
Study Start Date: July 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose group
Biological: GC1008
0.3 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 2
Dose Group
Biological: GC1008
1.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 3
Dose Group
Biological: GC1008
2.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 4
Dose Group
Biological: GC1008
4.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 5
Dose Group
Biological: GC1008
8.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent prior to any study-related procedures.
  • Patients should have an established diagnosis of IPF.
  • Pulmonary Function Tests (PFTs): FVC ≥ 50% and DLCO ≥ 25% of normal predicted values.
  • Able to walk at least 500 feet (150 meters) during the 6-minute Walk Test (6MWT). During the 6MWT the patient must not require greater than 51/min supplemental oxygen to maintain oxygen saturation > 80%

Exclusion Criteria:

  • Women who are pregnant or lactating; or who plan to become pregnant within 9 months after the infusion.
  • Women of childbearing potential or men who are considering fathering a child unless taking medically acceptable contraceptive precautions;
  • History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin.
  • History of clinically significant respiratory diseases other than IPF.
  • History of clinically significant cardiac, hepatic, or renal disease.
  • History of cancer, precancerous state (e.g. familial polyposis, BRCA1, BRCA2), other than non-melanomatous skin cancer, within 5 years prior to Screening.
  • Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening.
  • Other pathology that might interfere with the assessment of the safety or efficacy of the test article.
  • Other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125385


Locations
United States, Colorado
Denver, Colorado, United States, 80206
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States, 55905
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle, Washington, United States, 98195
Belgium
Belgium, Belgium
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00125385     History of Changes
Other Study ID Numbers: GC100800103
First Submitted: July 29, 2005
First Posted: August 1, 2005
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
IPF
Idiopathic
Pulmonary
Fibrosis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs