ISRCTN79334891进行中（未招募）4 期
Hydroxychloroquine in ANCA Vasculitis Evaluation (HAVEN): a multicentre, randomised, double-blind, placebo-controlled trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37024906/ (added 11/04/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years at screening
- •2. Clinical diagnosis of Granulomatosis Polyangiitis (GPA), Microscopic Polyangiitis (MPA), or Eosinophilic Granulomatosis with Polyangiitis (EGPA) according to the Chapel Hill criteria
- •3. Birmingham Vasculitis Activity Score (BVAS v.3) >3 with minor BVAS items only (no major BVAS items) at screening and randomisation
- •4. Receiving maintenance therapy at a stable dose for 4 weeks prior to randomisation
- •5. If receiving corticosteroids for reasons other than vasculitis must be on a stable regimen for 4 weeks prior to randomisation
- •6. Not pregnant or nursing. Is either: not of non-childbearing potential, for example, is postmenopausal (1 year without menses), or has had a hysterectomy, bilateral oophorectomy, documented tubal ligation, or other permanent sterilization procedure; or is of childbearing potential and has a negative urine pregnancy test at screening and at baseline and agrees to using an effective method of contraception. Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Partcipants of childbearing potential must consistently and correctly use of one of the following acceptable methods of birth control for 1 month prior to the start of the study agent, during the study, and 16 weeks after the last dose of study agent:
- •6.1. Oral contraceptive, either combined or progestogen alone
- •6.2. Injectable progestogen
- •6.3. Implants of levonorgestrel or etonogestrel
- •6.4. Estrogenic vaginal ring
- •6.5. Percutaneous contraceptive patches
- •6.6. Intrauterine device (IUD) or intrauterine system (IUS) with <1% failure rate as stated in the product label
- •7. No contraindications to hydroxychloroquine therapy and normal baseline visual fields at screening
- •8. Willing and able to give written informed consent to participate in the trial
- •9. Patients should have sufficient understanding of the English language to provide informed consent and complete the patient questionnaires
- •10. Negative urine drug screen should be performed prior to study entry
排除标准
- •1. Currently taking hydroxychloroquine or related antimalarial such as mepacrine or chloroquine
- •2. Estimated Glomerular Filtration Rate (eGFR) <30 ml/min
- •3. Weighing <40 kg
- •4. Sensitivity, anaphylaxis, or allergy to hydroxychloroquine or any other 4-aminoquinoline compound
- •5. Known glucose-6-phosphate dehydrogenase deficiency
- •6. Known lactose intolerance
- •7. Evidence of plaque psoriasis
- •8. Concomitant use of the following medications:
- •8.1. Tumour necrosis factor inhibitor treatment (e.g. etanercept)
- •8.2. Cyclophosphamide
- •8.3. Abatacept
- •8.4. Alemtuzumab
- •8.5. Any experimental or biological therapies
- •8.6. Intravenous, intramuscular or sub-cutaneous immunoglobin
- •8.7. Plasma exchange
- •8.8. Antithymocyte globulin
- •8.9. Tamoxifen
- •8.10. Live vaccines
- •9. B cell depleting therapy (rituximab) for remission induction. Rituximab maintenance therapy is permitted.
- •10. Severe or rapidly progressive ANCA vasculitis with at least one major Birmingham Vasculitis Activity Score (BVAS) item
- •11. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to vasculitis (i.e. cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious disease) which, in the opinion of the principal investigator, could confound the results of the study or put the patient at undue risk
- •12. Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix
- •13. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to randomisation
- •14. Have a historically positive test, or test positive at screening,for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody, or are known to be HIV-1 positive
- •15. Have a Grade 3 or greater laboratory abnormality based on the CTCAE toxicity scale (version 5), unless considered by the investigator to be related to the underlying disease or induction therapy
- •16. Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results, including QT interval corrected using the same consistent formula at each visit (QTc) of >470 msec (female participants) or >450 msec (male participants) demonstrated by at least two ECGs.
- •17. Participation in any other interventional trial within the last 6 months
- •18. Current symptomatic COVID-19 infection
- •19. Have been admitted to the ICU in the past 6 months due to a COVID-19 infection
研究者
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