ACTRN12606000187549尚未招募3 期
An Open-Label Extension Trial of Treprostinil Diethanolamine Sustained Release (UT-15C SR) in Subjects with Pulmonary Arterial Hypertension to assess the long-term safety of UT-15C SR in study subjects and the effect of continued therapy with UT-15C SR on exercise capacity after one year of treatment.
nited Therapeutics Corporation0 个研究点目标入组 450 人开始时间: 2006年5月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Participation in study TDE-PH-301 or TDE-PH-302 is required. Subjects must complete all assessments in one of these two studies to be eligible. Subjects who permanently discontinued study drug during the previous study (TDE-PH-301 or TDE-PH-302) due to treatment related adverse events are not eligible for entry into this study, even if they completed all remaining study visits in the previous study.Subjects who permanently discontinued study drug during the Treatment Phase of Study TDE-PH-301 or TDE-PH-302 due to clinical worsening (as defined in those study protocols) and who did not undergopremature termination assessments prior to discontinuing study drug, and/or who did not complete all remaining study visits through the final scheduled visit, are also not eligible for entry into this study.Subjects who permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301 or TDE-PH-302) due to clinical worsening, who completed premature terminationassessments prior to discontinuing study drug, and who completed all remaining scheduled study visits, are eligible for entry into this study. However, if the subject received active drug during the TreatmentPhase of the previous study (TDE-PH-301 or TDE-PH-302), then the subject may not participate in this study, as the subject previously clinically worsened on active drug. If the subject received placebo duringthe Treatment Phase of the previous study, then the subject is eligible for this study and should start treatment UT-15C SR in the open-label study at 1 mg twice daily.Inclusion Criteria: 1. The subject weighs a minimum of 45 kilograms at Screening. 2. The subject, if female, is physiologically incapable of childbearing or practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods [such as a condom or diaphragm] used with a spermicide, or an intrauterine device}.For women of childbearing potential, a negative serum pregnancy test will be required at Screening. 3. The subject has a diagnosis of symptomatic Idiopathic or Familial PAH (including PAH associated with appetite suppressant use), PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), PAH associated with Collagen Vascular Disease, or PAH associated with HIV. 4. The subject, if HIV positive, has a CD4 lymphocyte count = 200 within 30 days of Baseline and is receiving current standard of care anti-retroviral or other effective medication for treatment of HIV. 5. The subject must have a Baseline 6-Minute Walk distance of between 100 and 400 meters, inclusive. 6. The subject may benefit from the introduction of additional therapy (e.g. a prostacyclin) as determined by their medical provider. 7. The subject must have been optimally treated with approved oral therapies. Specifically, the subject:a. Has been receiving approved PDE-5 inhibitor or approved ERA therapy alone for at least 90 days and at the current stable dose for 30 days prior to Baseline and is willing to remain on PDE-5 inhibitor or ERA alone and at the same dose for the duration of the 16- week Treatment Phase orb. Has been receiving the combination of approved PDE-5 inhibitor and approved ERA therapy for at least 90 days prior to Baseline with both treatments at the current stable dose at least 30 days prior to Baseline and is willing to remain on the combination of PDE-5 inhibitor and ERA at the same dose for the duration of the
排除标准
- •1. The subject is pregnant or lactating.2. The subject has received epoprostenol, treprostinil, iloprost, beraprost, or any other prostacyclin therapy within 30 days of Baseline (except if used during acute vasoreactivity testing).3. The subject has had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, diuretic, digoxin) for pulmonary hypertension added within 30 days of Baseline.4. The subject has had any PAH medication except for anticoagulants discontinued within 30 days of Baseline.5. The subject has any disease associated with pulmonary arterial hypertension other than collagen vascular disease, HIV, or repaired congenital systemic-to-pulmonary shunts (repaired = 5 years)(e.g. portal hypertension, chronic thromboembolic disease, etc.).6. The subject has a current diagnosis of uncontrolled sleep apnea as defined by their physician.7. The subject has chronic renal insufficiency as defined by either a Screening creatinine value greater than 2.5 mg/dL (221 µmol/L) or the requirement for dialysis.8. The subject has anemia as defined by a Screening hemoglobin value of less than 10 g/dL.9. The subject has a history or current evidence of left-sided heart disease including previous myocardial infarction, or evidence of current left-sided heart disease as defined by PCWPm or LVEDP > 15 mmHg or left ventricular ejection fraction (LVEF) < 40% as assessed by either multigated angiogram (MUGA), angiography or echocardiography, or left ventricular (LV) shortening fraction < 22% as assessed by echocardiography, or symptomatic coronary artery disease (i.e., demonstratable ischemia either at rest or during exercise).10. The subject has significant parenchymal lung disease as evidenced by pulmonary function tests done within 6 months of Baseline as defined by any one of the following:a. Total Lung Capacity < 60% (predicted), orb. If Total Lung Capacity is between 60% and 70% of predicted, a high resolution CT scan must be performed to document diffuse interstitial fibrosis or alveolitis orc. Forced expiratory volume/forced vital capacity (FEV/FVC) ratio < 50%11. The subject has uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.12. The subject has a musculoskeletal disorder (e.g. hip replacement, artificial leg, etc.) or any other disease that is likely to limit ambulation, or is connected to a machine that is not portable.13. The subject has an unstable psychiatric condition or is mentally incapable of understanding the objectives, nature, or consequences of the trial, or has any condition which in the Investigator's opinion would constitute an unacceptable risk to the subject's safety.14. The subject is receiving an investigational drug, has an investigational device in place (except a Chronicle® device if in place and without complications for 30 days prior to Screening), or has participated in an investigational drug or device study within 30 days prior to Screening.
研究者
相似试验
终止
3 期
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEFPulmonary Hypertension Associated With HFpEFNCT03043651United Therapeutics48
已完成
3 期
An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionNCT01027949United Therapeutics894
已完成
3 期
A Phase 3b, open-label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who completed treatment in Study M16-046Eczema1000381610014982Atopic DermatitisNL-OMON55265AbbVie Deutschland GmbH & Co. KG15
已完成
不适用
A Long Term Safety Study of Apricitabine in HIV-infected PatientsPER-083-08AVEXA LIMITED,
进行中（未招募）
不适用
A phase 3, open-label 96-week extension study of the safety of apricitabine in treatment-experienced HIV-1 infected patients who have completed protocol AVX-301 or AVX-302 or who have met the criteria for open-label access to ATC because ofvirologic failure/lack of response. - AVX-303HIV-1MedDRA version: 9.1Level: LLTClassification code 10064446Term: HIV infection WHO clinical stage IEUCTR2008-001486-28-FRAvexa Limited1,866