Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Inoperable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
|First Received Date ICMJE||August 12, 2011|
|Last Updated Date||July 20, 2012|
|Start Date ICMJE||March 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To determine the effect on 6 minute walking test (6MWT) distance after 24 weeks following subcutaneous (sc) Treprostinil Sodium or Control in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension|
|Original Primary Outcome Measures ICMJE
||To determine the effect on 6MWT distance after 24 weeks following sc Treprostinil Sodium or Control in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension|
|Change History||Complete list of historical versions of study NCT01416636 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Inoperable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)|
|Official Title ICMJE||Double Blind Controlled Clinical Investigation Into the Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Inoperable) Chronic Thromboembolic Pulmonary Hypertension|
The primary purpose of this study it to determine the effect on 6 minute walking test (MWT) distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.
A Genetic Study investigating Vitamin K Epoxide Reductase Complex Subunit 1 in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by non-resolving organized thromboembolic obstructing the pulmonary vascular bed (Lang, 1994). These thrombi are resistant to thrombolytic therapy and chronic plasmatic anticoagulation. An increase in pulmonary vascular resistance (PVR), right ventricular overload, and eventually right ventricular failure ensue.
The treatment of choice for CTEPH is pulmonary endarterectomy (PEA), providing a potential cure for the disease (Klepetko, 2004)). However, about 50 % of patients are not candidates for surgery, mainly because of distal location of thromboemboli. Despite recent advances in the treatment of pulmonary arterial hypertension (PAH) (McLaughlin, 2004), medical treatments have not been recommended for inoperable CTEPH, because of the concept that a predominantly major vessel obstructive arteriopathy would not be suitable for vasodilators. Furthermore, a major drawback of i.v. prostacyclin therapy is the need for a permanent central venous access that increases the risk of infection (0.22-0.68 per patient per year) (Kuhn, 2003), thrombosis and new major vessel thromboembolism.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Condition ICMJE||Inoperable Chronic Thromboembolic Pulmonary Hypertension|
|Intervention ICMJE||Drug: Treprostinil natrium|
|Study Arm (s)||Active Comparator: Treprostinil, prostaglandine, subcutaneous infusion
Intervention: Drug: Treprostinil natrium
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Estimated Completion Date||September 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Written informed consent has been obtained
Patient should be notified of how their information will be handled and possibly shared with regulatory agencies when needed.
Males or females, ages >18 years, of any racial origin with severe CTEPH with at least 3 months anticoagulation.
Women of child bearing potential are surgically sterile or postmenopausal(amenorrhea for at least 12 months) or on acceptable form of birth control. A double barrier method of birth control, such as a condom and spermicide is mandatory.
An un-encouraged six minute walk (6MWT) test of between 150 and 400 meters
Cardiac catheterization within the past 6 months consistent with PH, specifically PAPm >25 mmHg (at rest), PCWP (or left ventricular end diastolic pressure) <15 mmHg, and PVR >3 mmHg/L/min
Within the past 12 months patients must have had a chest radiograph or an alternative diagnostic imaging consistent with the diagnosis of PH.
Be willing and able to follow all study procedures
Have any other form of pulmonary hypertension, pulmonary venous hypertension, peripheral vascular occlusive disease (PVOD) or PCH, or severe chronic obstructive pulmonary disease (COPD).
Be considering pregnancy, be pregnant and/or lactating
Have any acute concomitant disease other than those accepted as part of the inclusion criteria
Have received any prostanoid, within the 30 days before screening or be scheduled to receive any during the course of the study
Have an increased risk for hemorrhage (INR >3)
Have received any investigational medication within 30 days prior to the start of this study or be scheduled to receive another investigational drug during the course of this study
Have a known intolerance to any drug, especially to treprostinil sodium or prostanoids
Have a history or suspicion of inability to cooperate adequately
Have a new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for PAH added within the last month, excepting anticoagulants
Have any preexisting disease known to cause pulmonary hypertension (e.g., obstructive lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia, mitral valve stenosis, portal hypertension)
Have any musculoskeletal disease or any other disease that would limit ambulation.
Have any serious liver problems (Child-Pugh, class C), such as active gastrointestinal ulcer, intrabdominal hemorrhaging.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Austria, Czech Republic, Germany, Poland|
|NCT Number ICMJE||NCT01416636|
|Other Study ID Numbers ICMJE||116-02|
|Has Data Monitoring Committee||No|
|Responsible Party||Medical Research Network GmbH|
|Study Sponsor ICMJE||Medical Research Network GmbH|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Medical Research Network GmbH|
|Verification Date||July 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP