Status:
TERMINATED
A Study of Patients Having Pulmonary Hypertension Associated With Sickle Cell Disease and Completing an ASSET Study
Lead Sponsor:
Actelion
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Hypertension
Sickle Cell Anemia
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 ...
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 populati...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Completion of the 16-week treatment period in the double-blind ASSET study
- Women of childbearing potential must have a negative result on their serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.
- Reliable methods of contraception are:
- Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- Intra-uterine devices.
- Oral, injectable, transdermal or implantable contraceptives only in combination with a barrier method.
- Hormone-based contraceptives alone, regardless of the route of administration, are not considered to be reliable methods of contraception.
- Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
- Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
- Signed written informed consent is obtained from the patient or patient's parent/ legal representative prior to initiation of any study-related procedure.
- EXCLUSION CRITERIA
- All patients (Groups A and B):
- Any major protocol violation in the preceding double-blind ASSET study\*.
- Hemoglobin concentration less than 6.0 g/dL.
- Pregnancy or breast-feeding.
- \* Protocol violations will be reviewed by the monitor during site visits and discussed with the study staff on an ongoing basis and at the patient's completion of the double-blind study.
- Group B only:
- Acute liver disease.
- Newly diagnosed cirrhosis or portal hypertension.
- ALT greater than or equal to 3 times ULN and/or albumin greater than 20% below LLN.
- Newly diagnosed psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00360087
Start Date
March 1 2006
End Date
December 1 2007
Last Update
February 3 2025
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