jRCT2031260215尚未招募不适用
A Phase 2 Open-label Trial to Evaluate the Efficacy and Safety of Rusfertide in Japanese Patients with Polycythemia Vera
未提供0 个研究点目标入组 9 人开始时间: 待定
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 9
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
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Japanese male and female participants aged 18 years or older at the time of signing informed consent.
- •Participant understands the trial procedures, is willing and able to adhere to trial requirements and agrees to participate in the trial by giving written informed consent.
- •Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of Polycythemia Vera (PV).
- •Phlebotomy requiring defined as ALL of the following:
- •a) At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before trial intervention or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before trial intervention, and
- •b) Last phlebotomy due to inadequate hematocrit control within 3 months before trial intervention, and
- •c) No phlebotomy within 6 days prior to trial intervention (do not include day of phlebotomy and day of trial intervention in the 6-day count).
- •Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy.
- •Hematology test values at screening:
- •a) Hematocrit <45%,
- •b) WBC 4,000/microliter to 20,000/microliter (inclusive), and
- •c) Platelets 100,000/microliter to 1,000,000/microliter (inclusive).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or
- •Women of childbearing potential (WOCBP) agree to use at least 1 form of highly effective contraception during the trial and for 30 days after the last dose of trial intervention.
- •A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for a period of 30 days after receiving the last dose of trial medication.
- •A fertile man agree to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP partner(s) during the trial and for 90 days after the last dose of trial intervention.
- •A male participant must agree not to donate sperm for the purpose of reproduction during the trial and for a minimum of 90 days after receiving the last dose.
- •Participants receiving cytoreductive therapy (CRT) at trial intervention must be on a stable PV therapy regimen as follows:
- •a) Hydroxyurea - at least 8 weeks
- •b) Janus kinase (JAK) inhibitor - at least 8 weeks
- •c) Interferon - at least 24 weeks.
- •Note: A "stable dose regimen" of CRT does not mean an unchanged dose regimen. Temporary adjustments in dose regimen or temporary suspension of dosing are allowed. However, the total weekly dose of hydroxyurea and JAK inhibitor or total monthly dose of interferon may not be higher at trial intervention than the dose at the beginning of the pre-trial intervention observation period. The pre-trial intervention observation period is 8 weeks for hydroxyurea and JAK inhibitor and 24 weeks for interferon.
- •Participants treated with phlebotomy alone at trial intervention must have stopped:
- •a) Hydroxyurea at least 8 weeks before trial intervention
- •b) JAK inhibitor at least 8 weeks before trial intervention
- •c) Interferon at least 24 weeks before trial intervention.
排除标准
- •Clinically meaningful laboratory abnormalities at Screening including, but not limited to:
- •a) Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m^2
- •as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese*
- •eGFR=194 x (serum creatinine value) -1.094 x (age) - 0.287 x (sex correction factor),
- •Sex correction factor: 0.739 in female (Japanese Society of Nephrology,2023).
- •b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2.5 x upper limit of normal (ULN)
- •c) Total bilirubin >1.5 x ULN.
- •Note: Screening laboratory tests with abnormal results (if considered by the investigator to be transient and inconsistent with the participant's clinical condition) may be repeated within the screening window to confirm abnormal results. If results return to protocol acceptable limits within the screening period, the participant may enter the trial. Use local labs for all eligibility lab tests.
- •Participants who require phlebotomy at hematocrit levels lower than 45%.
- •Pregnant females will be ineligible to participate in this trial if, despite a negative pregnancy test, the investigator determines that based on interview, clinical assessment, or other relevant information that the individual may be in the very early stages of pregnancy.
- •Is capable of breastfeeding but does not agree to forego breastfeeding from the first dose of trial intervention through 30 days after the last dose of trial intervention.
- •Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to trial intervention.
- •Active or chronic bleeding within 2 months prior to trial intervention.
- •Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
- •Any infection requiring systemic therapy within 1 month of dosing except controlled: human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. Prophylactic therapies are allowed.
- •Any serious or unstable medical condition (eg, poorly controlled HIV infection) or uncontrolled psychiatric condition as judged by the investigator that would impair the participant's ability to participate in the trial.
- •Major surgical procedure within 2 months prior to trial intervention unless the participant has fully recovered from surgery or planned major elective surgery during the trial.
- •History of invasive malignancies within the last 5 years, except
- •a) localized cured cancer (eg, prostate cancer and cervical cancer)
- •b) localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.
- •Participants with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during the required dermatology examination at screening unless the cancer is adequately treated (ie, treatment that is expected to be curative, such as Mohs surgery) before trial intervention.
- •Note: Suspicious lesions should be biopsied and results available before trial intervention.
- •Participants with active alcohol or drug addiction that would interfere with their ability to comply with trial requirements.
- •Participants who do not complete at least 4 days of Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) assessments within 1 week prior to trial intervention.
- •Receipt of an investigational agent within 2 months or 5 half-lives, whichever is longer, prior to trial intervention.
- •Received busulfan within 7 months prior to screening.
- •Participants with hypersensitivity to rusfertide or to any of the excipients.
- •Participants with any lesion or mass detected by physical examination or imaging during screening that is suspicious for malignancy unless evaluated and assessed to be not malignant.
研究者
相似试验
招募中
1 期
A Phase 1b, Randomized, Open-Label Trial to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB097 in Combination with Pembrolizumab in Melanoma Patients with Primary Resistance to an Anti-PD-1-Containing Immunotherapy (MELODY-1)Advanced Melanoma2023-507377-17-00Microbiotica Limited27
招募中
1 期
An open-label, single-center study to evaluate the safety and test-retest characteristics of [11C]MODAG-005 as PET radioligand for imaging pathological alpha-synuclein deposition in the brains of patients with Parkinson’s disease (PD) or Multiple System Atrophy (MSA) compared to age-matched healthy controls (AMHC)Healthy VolunteerParkinson DiseaseMultiple System Atrophy2023-506965-72-00Modag GmbH28
尚未招募
不适用
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationGrade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationjRCT203126015910
招募中
不适用
An open-label, randomized controlled study of the manufacturing efficiency and clinical performance of digital radiotherapy prostheses for patients undergoing brachytherapy for tongue cancerTongue cancerjRCT103226003110
招募中
1 期
Phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-NNS309 in patients with pancreatic, lung, breast and colorectal cancers.2023-510356-23-00Novartis Pharma AG76