What side effects are associated with this type of intervention?

Common treatments for Polycythemia Vera include Pegylated Interferon Alpha-2b, hydroxyurea, and ruxolitinib. Pegylated Interferon Alpha-2b can cause flu-like symptoms, fatigue, depression, and liver enzyme abnormalities. Hydroxyurea may lead to cytopenias, mucocutaneous ulcers, diarrhea, peripheral neuropathy, and potential teratogenicity. Ruxolitinib is associated with cytopenias, dizziness, headache, fatigue, elevated serum cholesterol, and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Polycythemia Vera (PV) that focus on reducing the overproduction of red blood cells and modulating the immune system. Hydroxyurea is a commonly used cytoreductive agent that helps control blood cell production. Ruxolitinib, a JAK1/JAK2 inhibitor, is another FDA-approved drug that targets the JAK-STAT pathway involved in the overproduction of blood cells in PV. While not specifically FDA-approved for PV, Interferon Alpha has been used off-label to modulate the immune system and reduce red blood cell production, similar to the mechanism of Pegylated Interferon Alpha-2b (P1101) being studied in the trial.

What other types of research exist?

Promising novel alternatives to P1101 for Polycythemia Vera patients include: 1) Ruxolitinib, a JAK1/JAK2 inhibitor that has shown efficacy in reducing hematocrit levels and spleen size, and improving symptoms in PV patients. 2) Ropeginterferon alfa-2b, a long-acting interferon that has demonstrated effectiveness in controlling hematocrit and reducing JAK2 mutation allele burden with a favorable safety profile. 3) Rusfertide (PTG-300), a hepcidin mimetic that regulates iron metabolism and has shown potential in reducing the need for phlebotomies in PV patients. These alternatives offer different mechanisms of action and may provide additional options for managing PV.

← Back to Search

Interferon

ECLIPSE PV / A22-203

Phase 3

Recruiting

Research Sponsored by PharmaEssentia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 28 days

Treatment 48 weeks

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a medication called ropeginterferon alfa-2b-njft in adults with polycythemia vera, a type of blood cancer. The goal is to see how well it works and how safe it is. The medication helps the immune system control abnormal blood cells to prevent serious health issues. Ropeginterferon alfa-2b is a new form of treatment recently shown to be safe and effective in polycythemia vera.

Who is the study for?

Adults with Polycythemia Vera (PV) can join this trial if they have certain levels of hemoglobin, good liver function, adequate neutrophil counts, and sufficient kidney clearance. Women must not breastfeed and those who can bear children should use birth control during the study.

What is being tested?

The trial is testing P1101 (Ropeginterferon alfa-2b-njft), a medication for PV. It aims to see how well it works, its safety profile, and how tolerable it is for patients when taken as prescribed in the study protocol.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with interferons like P1101 may include flu-like symptoms, tiredness, mood changes, nausea, and injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver is functioning well according to recent tests.

Select...

My hemoglobin level is at least 10 g/dL if I am female, or 11 g/dL if I am male.

Select...

My kidneys are functioning well enough (creatinine clearance rate ≥40 mL/min).

Select...

I agree to use birth control during and 60 days after the study, and I won't breastfeed if participating.

Timeline

Screening ~ 28 days1 visit

Treatment ~ 48 weeks17 visits

Follow Up ~ 28 days1 visit

Screening ~ 28 days

Treatment ~ 48 weeks

Follow Up ~28 days

This trial's timeline: 28 days for screening, 48 weeks for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: P1101 250-350-500mcgExperimental Treatment1 Intervention

Pre-filled Syringe, Q2W starting at 250-350-500, SC injection

Group II: Ropeginterferon alfa-2b-njftActive Control1 Intervention

Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pegylated Interferon Alpha-2b works by modulating the immune system to reduce the overproduction of red blood cells, which is crucial for managing PV. Hydroxyurea, a cytoreductive agent, inhibits DNA synthesis, thereby reducing the proliferation of blood cells. Ruxolitinib, a JAK2 inhibitor, targets the JAK-STAT pathway, which is often dysregulated in PV, to control blood cell production and alleviate symptoms like splenomegaly and severe pruritus. These treatments are essential for PV patients as they help manage hematocrit levels, reduce the risk of thrombotic events, and improve overall quality of life.

Challenges and Perspectives for Therapeutic Targeting of Myeloproliferative Neoplasms.Acute myocardial infarction following sequential multi-vessel occlusion in a case of polycythemia vera.