MedTrace Logo

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

NCT00125385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

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.

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.

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.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125385 on ClinicalTrials.gov