Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02981082
Status:
TERMINATED
Last Update Posted:
2022-03-17
First Post:
2016-11-30
Brief Title:
Dimethyl Fumarate DMF in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
Sponsor:
Robert Lafyatis
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Double-blinded Placebo-controlled Pilot Study of Dimethyl Fumarate DMF in Pulmonary Arterial Hypertension PAH Associated With Systemic Sclerosis SSc-PAH The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blinded placebo-controlled study of Dimethyl fumarate DMF in 34 Systemic Sclerosis-Pulmonary Hypertension SSc-PAH patients The study will determine safety and the primary outcome variability for DMF in treating SSc-PAH the primary outcome of clinical efficacy in this pilot trial will be improvement in 6-minute walk distance 6MWD
Detailed Description:
A double-blinded placebo-controlled study of Dimethyl fumarate DMF in 34 Systemic Sclerosis-Pulmonary Hypertension SSc-PAH patients The study medication will be added to stable background PAH medications Subjects will be dosed for 24 weeks will undergo examination every 8 weeks and will be finally evaluated 12 weeks after completion of treatment Dosage will begin at once daily oral doses of 120mg for the first 7 days and follow the up-titration schedule to a maintenance dose of 240mg twice a day or highest tolerated dose of a minimum of 120mg twice a day by the start of Week 8 for the remainder of the study Participation will be for a total of 40 weeks including a 4-week screening period 24 weeks of drug and a safety follow-up 12 weeks after the last dose The study will determine the safety and the primary outcome variability for DMF in treating SSc-PAH the primary outcome of clinical efficacy in this pilot trial will be improvement in 6-minute walk distance 6MWD
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