Active — Not RecruitingPhase 2

A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

China49 participantsStarted 2021-10-08

Plain-language summary

This study is a phase II single-arm study designed to evaluate the efficacy and safety of P1101 in Chinese PV patients who are intolerance or resistance to HU.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Drug resistance: 3 months of treatment at HU doses above 2 g/d
. Phlebotomy is still required to maintain Hct \<45%;
. Failure to control the bone marrow proliferation (such as platelet count \>400x10\^9/L and white blood cell count \>10x10\^9/L);
. spleen shrinkage of less than \>50%;
. Intolerance
. At the minimum dose of HU required to achieve complete or partial clinical hematologic response, the absolute neutrophil count (ANC) \<1x10\^9/L or PLT \<100x10\^9/L or HGB \<100 g/L;
. At any dose of HU treatment, the patient develops lower limb ulcers or other intolerable non-hematologic toxicity, such as skin mucosal manifestations (dark skin, teeth or nails; oral ulcers, mucositis; skin ulcers, rash, and other symptoms), gastrointestinal complaints (nausea, loss of appetite, indigestion, vomiting, abdominal pain, constipation, and other symptoms), pneumonia, fever, etc.

Exclusion criteria

. Prior or current autoimmune thyroid disease, but patients with oral thyroxine replacement therapy could be enrolled;
. Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia \[ITP\], scleroderma, psoriasis or any autoimmune arthritis);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The phlebotomy- or erythrocytapheresis-free CHR rate based on the central laboratory test results evaluation

Timeframe: Week 24

Trial details

NCT IDNCT05485948

SponsorPharmaEssentia

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-07

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