NL-OMON50417已完成2 期
An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471. - N/A
Achillion Pharmaceuticals0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •Each participant must meet all of the following criteria to be enrolled in this
- •1. Must have completed the C3G Proof of Mechanism (POM) study (ACH471-201)
- •(participation in the long-term follow-up portion of ACH471-201 is not
- •Must meet all the following criteria:
- •a. Must have biopsy-confirmed primary C3G or IC-MPGN
- •b. Must have clinical evidence of ongoing disease based on significant
- •proteinuria (defined as *500 mg/day of protein in a 24-hour urine) attributable
- •to C3G disease or IC-MPGN in the opinion of the PI, and present prior to study
- •entry and confirmed during Screening.
- •c. If a pre-treatment biopsy is obtained, or if a historical biopsy is
- •available for review, it must have no more than 50% global fibrosis and no more
- •than 50% of glomeruli with cellular crescents
- •d. Must be 12 years or age or older and capable of swallowing tablets
- •2. If on corticosteroids, anti-hypertensive medications, anti-proteinuric
- •medications (e.g., ACE inhibitors or angiotensin receptor blockers [ARBs]), or
- •mycophenolate mofetil (MMF), must be on a stable dose for at least 2 weeks
- •prior to screening
- •3. Female participants of childbearing potential must agree to use an
- •acceptable method of contraception (as defined in Section 5.5.5) from the date
- •of signing the informed consent to the first day of dosing (Day 1), and must
- •agree to use a highly effective form of contraception (as defined in Section
- •5.5.5) from the first day of dosing to 30 days after their last dose of study
- •drug. Female participants of childbearing potential must also have a negative
- •serum pregnancy test during Screening and negative urine pregnancy test on Day
- •1. Female participants of non-childbearing potential need not employ a method
- •of contraception.
- •4. Non-sterile male participants must agree to use a highly effective form of
- •contraception (as defined in Section 5.5.5) with their partner(s) of
- •childbearing potential from the first day of dosing to 90 days after their last
- •dose of study drug. Male participants who are surgically sterile need not
- •employ additional contraception. Male participants must agree not to donate
- •sperm while enrolled in this study and for up to 90 days after their last dose
- •of study drug.
- •5. Adult participants must be capable of providing written informed consent and
- •adolescent participants must be capable of providing written assent. All
- •participants must be willing and able to comply with the requirements and
- •restrictions listed in the consent form and with all procedures in the
- •protocol, including, the visit schedule, the treatment plan, the schedule for
- •laboratory testing, and other study procedures
- •6. Must be up-to-date on routine vaccinations, or willing to be brought
- •up-to-date, based on local guidelines
- •7. Must have access to emergency medical care
排除标准
- •Participants who meet any of the following criteria will be excluded from the
- •1. Have a history of a major organ transplant (e.g., heart, lung, kidney,
- •liver) or hematopoietic stem cell/marrow transplant
- •2. Have a history or presence of any clinically relevant co-morbidities that
- •would make the participant inappropriate for the study (for example, a
- •comorbidity which is likely to result in deterioration of the participant*s
- •condition, affect the participant*s safety during the study, or confound the
- •results of the study), in the opinion of the PI
- •3. Have an estimated GFR <30 mL/min/1.73 m2 at the time of screening or at any
- •time over the preceding four weeks
- •4. Is a renal transplant recipient or receiving renal replacement therapy
- •5. Have other renal diseases that would interfere with interpretation of the
- •6. Have evidence of monoclonal gammopathy of unclear significance (MGUS),
- •infections, malignancy, autoimmune diseases, or other conditions to which C3G
- •or IC-MPGN is secondary
- •7. Have been diagnosed with or show evidence of hepatobiliary cholestasis
- •8. Females who are pregnant, nursing, or planning to become pregnant during the
- •study or within 90 days of ACH-0144471 administration or participants with a
- •female partner who is pregnant, nursing, or planning to become pregnant during
- •the study or within 90 days of ACH-0144471 administration
- •9. Have a history of febrile illness, a body temperature >38°C, or other
- •evidence of a clinically significant active infection, within 14 days prior to
- •ACH-0144471 administration
- •10. Have evidence of human immunodeficiency virus (HIV), hepatitis B infection,
- •or active hepatitis C infection at Screening
- •11. Have a history of meningococcal infection within the prior year
- •12. Have a history of hypersensitivity reactions to commonly used antibacterial
- •agents, including beta-lactams, penicillin, aminopenicillins, fluoroquinolones,
- •cephalosporins, and carbapenems, which, in the opinion of the investigator
- •and/or an appropriately qualified immunology or infectious disease expert,
- •would make it difficult to properly provide either empiric antibiotic therapy
- •or treat an active infection.
- •13. Have participated in a clinical study in which an investigational drug was
- •given within 30 days, or within 5 half-lives of the investigational drug,
- •whichever is longer, prior to the first dose of ACH-0144471
- •14. Have received eculizumab at any dose or interval within the past 50 days
- •prior to the first dose of ACH-0144471
- •15. Have received tacrolimus or cyclosporine within 2 weeks of the first dose
- •of ACH-0144471
- •16. Have a 12-lead ECG with a QTcF >450 msec for males or >470 msec for
- •females, or have ECG findings which, in the opinion of the PI, could put the
- •participant at undue risk
- •17. Have received any drug known to prolong the QTc interval within 2 weeks of
- •the first dose of ACH-0144471 and which, in the opinion of the PI, could put
- •the participant at undue risk
- •18. Have any of the following laboratory abnormalities at screening:
- •* Alanine transaminase (ALT) > upper limit of normal (ULN)
- •* Aspartate aminotransferase (AST) > ULN
- •* Absolute neutrophil counts (ANC) <1,000/*L
- •* Total bilirubin >1.5× ULN
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