ACTRN12619001643167招募中2 期
A Phase 2 prospective multi-centre, parallel group study to evaluate the safety, tolerability, and activity of ACT001 in Adult participants with Progressing Fibrosing Interstitial Lung Disease (PF-ILD), including Idiopathic Pulmonary Fibrosis (IPF) when used alone or in combination with standard of care therapy.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adult patients aged = 18 years at Consent
- •2. Fibrosing lung disease on high resolution computerized tomography (HRCT), defined
- •as reticular abnormality with traction bronchiectasis with or without honeycombing,
- •with disease extent of over 10%, performed within 12 months of Visit 1. If the HRCT is
- •outside of the 12 months window, a scan needs to be performed during Screening and
- •prior to Visit 2 to confirm the diagnosis.
- •3. For participants with underlying Connective Tissue Disease (CTD): stable CTD not
- •requiring initiation of new therapy. If the patient has a pulmonary fibrosis component
- •as part of the CTD and is progressing, this patient can be included.
- •4. Pulmonary function at baseline reporting FVC of greater than 45% and DLCO of greater than 30%
- •5. Able to complete home based spirometry reading as determined by investigator
- •6. Female participants are eligible if they are of. Non-childbearing potential, defined as
- •i. Previous hysterectomy or bilateral oophorectomy
- •ii. Previous bilateral tubal ligation
- •iii. Post-menopausal (total cessation of menses for greater than or equal to 1 year)
- •d. Childbearing potential with a negative urine pregnancy test at screening, prior
- •to investigational product administration, and uses highly effective
- •contraception 28 days prior to commencement of study drug and throughout
- •the study until 3 months after the last investigational product administration.
- •Highly effective contraception, when used consistently and in accordance with
- •both the product label and the instructions of the physician, are defined as
- •i. Vasectomized partner who is sterile prior to the female patient’s
- •enrolment and is her sole sexual partner
- •ii. An intrauterine device (IUD) with a documented failure rate of less
- •than 1% per year (i.e. Copper or hormone-releasing IUD)
- •iii. Double barrier contraception defined as condom with a female
- •iv. Combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation and a barrier
- •v. Progestogen-only hormonal contraception associated with inhibition of
- •ovulation and a barrier method
- •vi. Sexual abstinence or in same sex relationship
- •For men and women, acceptable methods of contraception include use of a condom
- •with spermicide or use of oral, implantable or injectable contraceptives, or IUD or a
- •diaphragm with spermicide or diaphragm with condom.
- •7. Male participants with a potentially fertile partner are eligible if they have had a
- •vasectomy or are willing to use adequate contraception 28 days prior to
- •commencement of study drug administration and throughout the study until 3 months
- •after the last investigational product administration. Female partners of male
- •participants are advised to also use contraception as noted above.
排除标准
- •1. History of chronic pulmonary obstructive disease that requires treatment, severe
- •pulmonary hypertension, drug-induced pulmonary toxicity, other forms of
- •idiopathic pneumonia, or interstitial lung diseases associated with environmental
- •exposure medication or systemic disease. Should the Investigator feel that a patient
- •would be suitable for inclusion into the study, but have components of their disease that fit into the above description, they should discuss this with the study Medical
- •Monitor for consideration.
- •2. Pre-existing hypersensitivity to ACT001 or related compounds
- •3. Major extrapulmonary physiological restriction
- •4. Cardiovascular diseases as determined by the investigator to be sufficient to exclude
- •from participation, such as severe hypertension, myocardial infarction within 6
- •months prior or unstable cardiac angina within 6 months
- •5. Creatinine clearance <30mL/min calculated per the Cockcroft-gault equation
- •6. Hepatic impairment as defined as AST or ALT >1.5 x upper limit of normal (ULN)
- •with or without elevated bilirubin > 1.5 x ULN
- •7. History of thrombotic event (including stroke and transient ischemic attack) within
- •8. Other disease that may interfere with testing procedures or in the judgment of the
- •Investigator may interfere with trial participation or may put the patient at risk when
- •participating in this study
- •9. Women of childbearing potential not willing or able to use highly effective methods
- •of birth control that result in a low failure rate of less than 1% per year when used
- •consistently and correctly, as well as one barrier method for 28 days prior to and 3
- •months after ACT001 administration. Male participants are also required to use
- •suitable contraception for 28 days prior to and 3 months after last ACT001
- •administration.
- •10. Current use of other investigational agents
- •11. Commencement or alteration of immune suppression or anti-fibrotic dosing within
- •3 months of screening. If a patient requires a short course of steroids that is NOT
- •for the purpose of immune suppression, this should be discussed with the study
- •Medical Monitor as it may be appropriate to still include the patient.
研究者
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