Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Male or female subjects aged ≥18 years at the time of signing the informed consent form. 2. Subjects diagnosed with PV according to the 2016 World Health Organization (WHO) criteria. 3. 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. 4. Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening. 5. Neutrophil count ≥1.5 × 109/L at screening. 6. Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula) 7. 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 (see Appendix 4 for details) 8. Written informed consent obtained from the subject or legally authorized representative, and ability for the subject to comply with the requirements of the study.
Exclusion Criteria:1. Any contraindications to interferon alfa or hypersensitivity to interferon alfa. 2. Have received previous interferon alfa or ruxolitinib therapy. 3. With severe or serious diseases that the Investigator determines may affect the subject's participation in this study. 4. History of major organ transplantation. 5. Pregnant or breastfeeding women. 6. 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: 7. 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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ray Urbanski, MD/PhD|
|Principal Investigator Affiliation||PharmaEssentia USA Corporation|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Experimental: Ropeginterferon alfa-2b-njft (P1101)
Pre-filled Syringe, Q2W, SC injection
Drug: - Ropeginterferon alfa-2b-njft (P1101)
Ropeginterferon alfa-2b-njft (P1101)
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.
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