跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/PER-019-21
PER-019-21尚未招募3 期

A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY,PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME(aHUS)

F. HOFFMANN-LA ROCHE LTD.0 个研究点目标入组 0 人开始时间: 2021年12月7日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
3 期
状态
尚未招募
研究概览入排标准研究者记录与标识符相似试验

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

性别
All

入选标准

  • •- Signed Informed Consent Form
  • •- Signed Assent Form when appropriate, as determined by patient's age and individual site and country standards
  • •- Age = 12 years at time of signing Informed Consent Form or Assent Form
  • •- Body weight = 40 kg at screening
  • •- Willingness and ability to comply with all study visits and procedures
  • •- Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first study drug administration. Vaccination currency should be maintained throughout the study in accordance with most current local guidelines or standard-of-care as applicable in patients with complement deficiency.
  • •- Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae,
  • •according to national vaccination recommendations (e.g., Advisory Committee on
  • •Immunization Practices guidelines). If not previously done, vaccination administered no later than one week after the first study drug administration.
  • •- For patients receiving other therapies (e.g., immunosuppressants, corticosteroids,
  • •mammalian target of rapamycin inhibitor [mTORi]; [i.e., sirolimus, everolimus] or calcineurin inhibitors [i.e., cyclosporine or tacrolimus]): stable dose for =28 days prior to screening and up to the first drug administration.
  • •- Adequate hepatic function, ALT = 3 x ULN at the time of screening; no clinical signs or known laboratory/radiographic evidence consistent with cirrhosis
  • •- For female patients of childbearing potential, an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
  • •- Patients with a prior kidney transplant are eligible if they have:
  • •o Known history of complement-mediated aHUS prior to the kidney transplant
  • •For Naive Cohort only:
  • •- Evidence of TMA, as defined by a patient with all of the following laboratory findings at screening and up to the first drug administration:
  • •o Platelet count < LLN
  • •o LDH = 1.5 x ULN and hemoglobin = LLN for age and sex
  • •o Serum creatinine =ULN in adults, or = 97.5th percentile for age in adolescents
  • •(12-18 years). Patients who require dialysis for acute kidney injury are also eligible.

排除标准

  • •TMA associated with non-aHUS related renal disease
  • •Positive direct Coombs test
  • •Identified drug exposure-related TMA
  • •History of organ transplant, other than kidney transplant
  • •Chronic dialysis (defined as dialysis for more than 4 weeks since TMA presentation), and/or end stage renal disease
  • •History of a kidney disease, other than aHUS, affecting renal function, such as:
  • •Known kidney biopsy finding suggestive of underlying disease other than aHUS
  • •Known kidney ultrasound finding consistent with an alternative diagnosis to aHUS
  • •Known family history and/or genetic diagnosis of non-complement mediated genetic renal disease
  • •History of Neisseria meningitidis infection within 6 months prior to screening and up to the first drug administration
  • •Known or suspected immune deficiency (e.g., history of frequent recurrent infections)
  • •Positive HIV test
  • •Life expectancy of < 4 weeks
  • •Active systemic bacterial, viral, or fungal infection within 14 days before first drug
  • •administration
  • •Presence of fever (=38 °C) within 7 days before the first drug administration
  • •Patient with active or evolving multi-system organ dysfunction or failure
  • •Immunized with a live attenuated vaccine within 1 month before first drug administration
  • •Known systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome
  • •Patients receiving chronic IV immunoglobulin (IVIg) within 8 weeks prior to start of
  • •screening, unless for unrelated medical condition (e.g., hypogammaglobinemia)
  • •History of malignancy within 5 years prior to screening and up to the first drug
  • •administration, with the following exceptions:
  • •- Patients with any malignancy treated with curative intent and the malignancy has been in remission without treatment for ?5 years prior the first drug administration are eligible.
  • •- Patients with curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix at any time prior to first drug administration, with no evidence of recurrence, are eligible.
  • •- Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below,
  • •Stage 1 or 2) with no requirement for therapy at any time prior the first drug administration are eligible.
  • •- History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in crovalimab, including hypersensitivity to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product
  • •- Female patients who are pregnant, breastfeeding, or have the intention of becoming pregnant during the study or within 6 months after the final dose of the study treatment.
  • •- Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
  • •- Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within five half-lives of that investigational product, whichever is greater. Patients enrolled in an eculizumab or ravulizumab interventional study are eligible for the Switch Cohort, provided they fulfill eligibility and stop their current trial.
  • •- Substance abuse within 12 months prior to screening, in the investigator's judgment
  • •- Splenectomy <6 months prior to screening
  • •- Use of tranexamic acid within 7 days prior to screening
  • •- Concurrent disea

研究者

相似试验

招募中
3 期
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic Syndrome
JPRN-jRCT2041210086Mona D. Shah45
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
EUCTR2020-002475-35-HUF. Hoffmann-La Roche Ltd90
进行中（未招募）
3 期
Clinical trial study for atypical hemolytic uremic syndrome in childrens aged more than 28 days to less than 18 years.
CTRI/2023/12/060590F HoffmannLa Roche Ltd
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic Syndrome (aHUS)MedDRA version: 20.1Level: LLTClassification code 10079841Term: Atypical hemolytic uremic syndromeSystem Organ Class: 100000004851
EUCTR2020-002437-15-HUF.Hoffmann-La Roche Ltd35
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic Syndrome (aHUS)MedDRA version: 20.1Level: LLTClassification code 10079841Term: Atypical hemolytic uremic syndromeSystem Organ Class: 100000004851
EUCTR2020-002437-15-BEF.Hoffmann-La Roche Ltd45