An Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 319
- 试验地点
- 50
- 主要终点
- 7. Change in N-terminal pro-brain natriuretic peptide
研究概览
简要总结
To evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Ole ( Open Label Extension Period)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subject gives voluntary informed consent to participate in the study.
- •The subject participated in RIN-PF-301, RIN-PF-303 or RIN-PF-305 and had 1 of the following applied: a. Remained on study drug and completed all scheduled study visits b. Was enrolled in RIN-PF-301, RIN-PF-303 or RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
- •Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to do 1 of the following: a. Abstain from intercourse (when it is in line with their preferred and usual lifestyle) b. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide. Women who are successfully sterilized or postmenopausal are not considered to be of reproductive potential.
- •Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
- •In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
排除标准
- •Subject is pregnant or lactating.
- •In the opinion of the Investigator, enrollment in RIN-PF-302 would represent a risk to the subject’s overall health.
- •Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement). Subjects participating in non-interventional, observational, or registry studies are eligible.
结局指标
主要结局
7. Change in N-terminal pro-brain natriuretic peptide
7. Change in N-terminal pro-brain natriuretic peptide
4. Overall survival
4. Overall survival
5. Change in % predicted FVC
5. Change in % predicted FVC
Efficacy will be assessed by evaluating the effect of continued long-term therapy with inhaled Treprostinil on the following parameters: 1. Change in absolute FVC
Efficacy will be assessed by evaluating the effect of continued long-term therapy with inhaled Treprostinil on the following parameters: 1. Change in absolute FVC
2. Time to clinical worsening (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC)
2. Time to clinical worsening (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC)
3. Time to acute exacerbation of IPF or ILD
3. Time to acute exacerbation of IPF or ILD
6. Change in K-BILD score
6. Change in K-BILD score
8. Change in DLCO
8. Change in DLCO
9. Change in resting supplemental oxygen use
9. Change in resting supplemental oxygen use
SAFETY ENDPOINTS Safety will be assessed by reviewing the following parameters: • AEs and serious adverse events (SAEs) • Clinical laboratory parameters •Vital signs, including resting saturation of peripheral capillary oxygenation (SpO2) • 12-lead electrocardiograms (ECGs)
SAFETY ENDPOINTS Safety will be assessed by reviewing the following parameters: • AEs and serious adverse events (SAEs) • Clinical laboratory parameters •Vital signs, including resting saturation of peripheral capillary oxygenation (SpO2) • 12-lead electrocardiograms (ECGs)
次要结局
未报告次要终点
研究者
Peter Smith
Scientific
United Therapeutics Corp.