A Phase 3 interventional study of P1101 (Ropeginterferon alfa-2b) in Polycythemia Vera (PV), sponsored by PharmaEssentia Japan K.K.. Recruiting at 6 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by PharmaEssentia Japan K.K. · Phase 3, Interventional, and Treatment
This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.
The study is to evaluate the long-term safety and efficacy of P1101 in PV or ET patients who participated in Study A19-201 or Study P1101 ET. The subjects who have completed the 52-week P1101 treatment duration in Study A19-201 will start treatment with P1101 at the dose at Week 50. The subjects who have completed the follow-up/end-of-study visit in Study P1101 ET will start treatment with P1101 at the dose at Week 50. The subjects who were treated with anagrelide will start treatment with P1101 at a dose of 250 μg. The dose of P1101 during this study may be increased or decreased up to 500 μg depending on the condition.
Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.
Efficacy evaluations, safety assessments, and immunogenicity evaluations of P1101 will be performed.
Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's planned enrollment of 67 is above the median of 52 across 204 interventional studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →PharmaEssentia Japan K.K. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional treatment based on phlebotomies, lowdose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of pegylated prolineinterferon alpha-2b (P1101, Ropeginterferon alfa-2b) once every 2 weeks.
Biological: P1101 (Ropeginterferon alfa-2b)
The subjects who have completed the 52-week treatment duration in Study A19-201 will be treated with P1101, starting at the dose at Week 50. The dose during this study may be increased or decreased up to 500 μg depending on the condition. This study will be continued as a post-marketing clinical study after acquisition of the marketing approval of P1101.
Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks
CHR will be defined as follows. * Hematocrit \<45% phlebotomy-free (absence of phlebotomy during the previous 12 weeks) * Platelet count ≤ 400 x 10\^9/L * WBC count ≤ 10 x 10\^9/L
Time frame: Through study completion, an average of 2 year
Changes in hematocrit every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Changes in white blood cell every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Changes in platelet count every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Changes in red blood cell count every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Changes in spleen size every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Necessity of phlebotomy
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Proportion of subjects without thrombotic or hemorrhagic events
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Time frame: Through study completion, an average of 2 year
Bone marrow histological remission (optional)
Bone marrow histological remission was defined as the disappearance of hypercellularity and trilineage growth (panmyelosis), and absence of \>grade 1 reticulin fibrosis in the subjects who gave informed consent in Study A19-201
Time frame: Through study completion, an average of 2 year
Plan to share: No
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Studies of the drug tested here: Ropeginterferon alfa-2b
PharmaEssentia Japan K.K.