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Active, not recruiting Phase 3 Interventional

P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

ClinicalTrials.gov ID: NCT06468033

Public ClinicalTrials.gov record NCT06468033. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 9:38 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk. Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

Study identification

NCT ID
NCT06468033
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
PharmaEssentia
Industry
Enrollment
160 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 17, 2025
Primary completion
Nov 17, 2027
Completion
Jan 10, 2029
Last update posted
Aug 12, 2026

2025 – 2029

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
USC Norris Comprehensive Cancer Center Los Angeles California 90033
Georgetown University Medical Center Washington D.C. District of Columbia 20007
University of Kansas Medical Center (KUMC) Kansas City Kansas 66103
American Oncology Partners of Maryland PA (Center for Cancer and Blood Disorders) Bethesda Maryland 20817
Washington University School of Medicine St Louis Missouri 63110
Weill Medical College of Cornell University New York New York 10021
Stony Brook University Medical Center Stony Brook New York 11794
Levine Cancer Institute Charlotte North Carolina 28204
Duke University Durham North Carolina 27710
Ohio State University Columbus Ohio 43210
MD Anderson Cancer Center Houston Texas 77030
Virginia Commonwealth University Richmond Virginia 23284
University of Washington Medical Center - Fred Hutchinson Cancer Center Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06468033, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 12, 2026 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06468033 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →