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OpenTrials
Completed

NCT Number: NCT00125385

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GC1008

Biological

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.

Primary outcomes

  1. 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 outcomes

  1. To evaluate potential clinical outcomes and bioactivity of GC1008

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2005
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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