Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360087
Status:
TERMINATED
Last Update Posted:
2010-02-12
First Post:
2006-08-02
Brief Title:
A Study of Patients Having Pulmonary Hypertension Associated With Sickle Cell Disease and Completing an ASSET Study
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Long-Term Open-Label Multicenter Extension Study of Bosentan in Patients With Pulmonary Hypertension Associated With Sickle Cell Disease Completing a Double-Blind ASSET Study AC-052-368 or AC 052-369
Status:
TERMINATED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSET-3
Brief Summary:
This study will assess the safety and efficacy of bosentan therapy in a study known as ASSET for patients who have high blood pressure in the lungs associated with sickle cell disease That form of hypertension places people at risk for complications including shortness of breath pain pneumonia and death Previous studies have shown that bosentan can be helpful in reducing pulmonary hypertension
Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2 study and who are not pregnant or breastfeeding may be eligible for this study The research will be conducted in about 25 hospitals in the United States and Europe Up to 30 participants will be enrolled The screening visit will involve a physical examination blood sample of about 3 teaspoons for laboratory tests and a pregnancy test Patients doctors will give them bosentan tablets 625 mg each to take one in the morning and one in the evening After 1 month patients will be told whether the dose should be increased to 125 mg tablets to take twice a day Two weeks after the increase in dose a blood test will be done to analyze the drugs effects on the liver After the start of treatment patients will return for visits every 6 months when there will be a 6-minute walking test to measure exercise capacity and evaluate shortness of breath There will be follow-up for patients up to the end of the study and for 28 days after the last dose of bosentan is taken to collect information about side effects
Some patients on bosentan have had changes in liver function and red blood cell count Side effects commonly reported are headache flushed appearance inflammation of the throat and nasal passages and gastrointestinal symptoms If patients have sudden worsening in breathing in the first few weeks after taking bosentan they should immediately tell their doctors because it may be necessary to change the treatment
Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2 study and who are not pregnant or breastfeeding may be eligible for this study The research will be conducted in about 25 hospitals in the United States and Europe Up to 30 participants will be enrolled The screening visit will involve a physical examination blood sample of about 3 teaspoons for laboratory tests and a pregnancy test Patients doctors will give them bosentan tablets 625 mg each to take one in the morning and one in the evening After 1 month patients will be told whether the dose should be increased to 125 mg tablets to take twice a day Two weeks after the increase in dose a blood test will be done to analyze the drugs effects on the liver After the start of treatment patients will return for visits every 6 months when there will be a 6-minute walking test to measure exercise capacity and evaluate shortness of breath There will be follow-up for patients up to the end of the study and for 28 days after the last dose of bosentan is taken to collect information about side effects
Some patients on bosentan have had changes in liver function and red blood cell count Side effects commonly reported are headache flushed appearance inflammation of the throat and nasal passages and gastrointestinal symptoms If patients have sudden worsening in breathing in the first few weeks after taking bosentan they should immediately tell their doctors because it may be necessary to change the treatment
Detailed Description:
The object of this study is to assess long-term safety tolerability and efficacy of bosentan in patients with pulmonary hypertension PH associated with sickle cell disease SCD The study population will include male and female patients with sickle cell disease SSS-beta-Thalassemia who have previously completed the 16-week treatment period of the double-blind study of bosentan ASSET 1 or ASSET 2 Patients who meet all the inclusion criteria and none of the exclusion criteria will be started on 625 mg bid for 4 weeks and then start the maintenance dose of 125 mg bid or stay on 625 mg if their weight is less than 40kg90lbs Patients will be divided into two groups Group A will consist of patients who begin this study within 4 weeks of completing ASSET 1 or ASSET2 Group B will consist of patients who begin this study longer than 4 weeks after completing ASSET I or ASSET 2 Patients will remain on drug until the FDA approves the drug for use in patients with pulmonary hypertension or until the sponsor decides to stop the study
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