NCT05481151进行中（未招募）3 期
A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)
PharmaEssentia23 个研究点 分布在 2 个国家目标入组 111 人开始时间: 2022年10月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 111
- 试验地点
- 23
- 主要终点
- Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24.
研究概览
简要总结
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
详细描述
Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML)
Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.
This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 years at the time of signing the informed consent form
- •Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
- •Subjects with good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin >3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
- •Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
- •Neutrophil count ≥1.5 × 10^9/L at screening
- •Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
- •Males and females of childbearing potential, as well as all women <2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study
- •Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study
排除标准
- •Any contraindications to interferon alfa or hypersensitivity to interferon alfa
- •Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
- •Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
- •History of major organ transplantation
- •Pregnant or breastfeeding women
- •Subjects with any other diseases that the Investigator determines will affect the study results or may weaken the compliance to protocol, including but not limited to:
- •Prior or current autoimmune thyroid disease (clinical symptoms of hyper- or hypo-thyroidism), except subjects with controlled thyroid replacement therapy, could be enrolled
- •Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia [ITP], scleroderma, psoriasis, or any autoimmune arthritis)
- •Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia, or a past history of interstitial pneumonia at screening
- •Active infection with systemic manifestations (e.g., presence of bacteria, fungi, and/or human immunodeficiency virus [HIV] at screening, excluding hepatitis B [HBV] and/or hepatitis C [HCV] at screening)
- •Evidence of severe retinopathy (e.g., cytomegalovirus [CMV]-induced retinitis, macular degeneration) or clinically significant eye diseases (due to diabetes or hypertension)
- •History or presence of clinically relevant depression per Investigator's judgment
- •Previously had suicidal attempts or has any risk for suicidal tendency at screening
- •Poorly controlled diabetes defined as HbA1c >8.0% for at least 1 year
- •Active thromboembolic complications caused by PV and abdominal hemorrhage in the active phase
- •History of any malignancy within 5 years (except adequately treated non-melanoma skin cancer, prostate cancer status post resection with an undetectable prostate-specific antigen (PSA), curative treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study)
- •History of alcohol or drug abuse in the past year
- •History or evidence of post-polycythemia vera-myelofibrosis (PPV-MF), essential thrombocythemia, or any non-PV MPN
- •Presence of blast cells in the peripheral blood in the past 12 weeks
- •Use any investigational drug <4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug
- •Any subject requiring a legally authorized representative
研究组 & 干预措施
P1101 250-350-500mcg
Experimental
Pre-filled Syringe, Q2W starting at 250-350-500, SC injection
干预措施: P1101 (Ropeginterferon alfa-2b-njft) (Drug)
Ropeginterferon alfa-2b-njft
Active Comparator
Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection
干预措施: Ropeginterferon alfa-2b-njft (P1101) (Drug)
结局指标
主要结局
Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24.
时间窗: 24 weeks
CHR is defined as hematocrit (HCT) \<45%, white blood cell (WBC) count \<10 × 10\^9/L, platelets (PLT) ≤400 × 10\^9/L in the absence of phlebotomy in the previous 12 weeks.
次要结局
未报告次要终点
研究者
研究点 (23)
Loading locations...
相似试验
已完成
1 期
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D InfectionChronic Hepatitis B InfectionChronic Hepatitis D InfectionNCT04638439PharmaEssentia20
已完成
3 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)Pneumococcal InfectionsNCT03480802Merck Sharp & Dohme LLC302
已完成
3 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)Pneumococcal InfectionsNCT03547167Merck Sharp & Dohme LLC1,515
已完成
3 期
A Phase III Trial to Assess the Safety and Immunogenicity of a HIPRA's Candidate Booster Vaccination Against COVID-19.COVID-19SARS-CoV-2 Acute Respiratory DiseaseNCT05246137Hipra Scientific, S.L.U2,646
已完成
3 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)Pneumococcal InfectionsNCT03480763Merck Sharp & Dohme LLC652