Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162760
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2005-09-08
Brief Title:
Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine whether thalidomide can stop the progression of fibrosis in IPF
The primary objective of this study is to determine the safety feasibility and efficacy of 400 mg of thalidomide administered daily for one year in patients with idiopathic pulmonary fibrosis IPF who have failed or are not candidates for treatment with corticosteroids andor cytotoxic drugs
The study population will consist of patients with biopsy-proven moderate to severe IPF who have failed or are not candidates for standard therapy with corticosteroids andor cytotoxic drugs
The primary objective of this study is to determine the safety feasibility and efficacy of 400 mg of thalidomide administered daily for one year in patients with idiopathic pulmonary fibrosis IPF who have failed or are not candidates for treatment with corticosteroids andor cytotoxic drugs
The study population will consist of patients with biopsy-proven moderate to severe IPF who have failed or are not candidates for standard therapy with corticosteroids andor cytotoxic drugs
Detailed Description:
This is an unmasked Phase II safety and efficacy trial of subjects with biopsy-proven IPF who have failed or are not candidates for standard therapy with corticosteroids andor cytotoxic drugs The study doctors are interested in studying the effects of the oral drug ThalomidR on IPF ThalomidR thalidomide is an approved medication for Hansens disease leprosy It is know to have anti-inflammatory effects and effects on fibrosis It is hoped that ThalomidR may prevent progression of IPF
Thalidomide is investigational for this use which means that it has not been approved by the US Food and Drug Administration FDA for the treatment of IPF
The age range for this study is 50-80 years inclusive There are 6 visits over the 12 month period These visits include physical exams pregnancy tests if applicable several symptom scales and questionnaires about your pulmonary fibrosis pulmonary function testing x-raysperipheral nerve testing and blood tests including arterial blood gas measurements You will be given the medication in capsule form every 28 days for a year There is a set schedule for increasing the doses of the thalidomide every 2 weeks until it reaches the 400 mg dose that is being studies A stool softener is also provided for each participant
All subjects must read sign and follow a manual of precautions prepared by Celgene the manufacturer of ThalomidR before enrolling in this study This manual containing the STEPSR precautions will be given to all participants
This study is being conducted at the Johns Hopkins Medical Institutions located in Baltimore Maryland
Thalidomide is investigational for this use which means that it has not been approved by the US Food and Drug Administration FDA for the treatment of IPF
The age range for this study is 50-80 years inclusive There are 6 visits over the 12 month period These visits include physical exams pregnancy tests if applicable several symptom scales and questionnaires about your pulmonary fibrosis pulmonary function testing x-raysperipheral nerve testing and blood tests including arterial blood gas measurements You will be given the medication in capsule form every 28 days for a year There is a set schedule for increasing the doses of the thalidomide every 2 weeks until it reaches the 400 mg dose that is being studies A stool softener is also provided for each participant
All subjects must read sign and follow a manual of precautions prepared by Celgene the manufacturer of ThalomidR before enrolling in this study This manual containing the STEPSR precautions will be given to all participants
This study is being conducted at the Johns Hopkins Medical Institutions located in Baltimore Maryland
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None