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Clinical Trial Finder

Search Results

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

Study Purpose

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Main

Inclusion Criteria:

All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria.
  • - Male and female subjects aged 18 (or the country specific minimum age of consent >18) years or older.
  • - Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera and have either JAK2 V617F mutation or JAK2 exon 12 mutation.
  • - At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization.
  • - CBC values immediately prior to randomization: 1.
Hematocrit <45%, 2. WBC 4000/μL to 20,000/μL (inclusive), and. 3. Platelets 100,000/μL to 1,000,000/μL (inclusive)
  • - Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen.
  • - Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.
Main

Exclusion Criteria:

Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria.
  • - Clinically meaningful laboratory abnormalities at Screening.
  • - Subjects who require phlebotomy at hematocrit levels lower than 45%.
  • - Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
  • - Active or chronic bleeding within 2 months prior to randomization.
  • - History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer.
  • - Subjects with non-invasive non-melanomatous (e.g., squamous cell or basal cell carcinoma) skin cancer during screening unless adequately treated before randomization.
  • - Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.

Trial Details

Trial ID:

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.

NCT05210790
Phase

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.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Protagonist Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Polycythemia Vera
Additional Details

Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks.

Arms & Interventions

Arms

Experimental: Rusfertide

Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)

Experimental: Placebo

Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)

Interventions

Drug: - Placebo

Placebo

Drug: - Rusfertide

Experimental drug

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

BRCR Medical Center, Plantation, Florida

Status

Recruiting

Address

BRCR Medical Center

Plantation, Florida, 33322

Site Contact

Jason Tache, MD

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Bethesda, Maryland

Status

Recruiting

Address

American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)

Bethesda, Maryland, 20817

Site Contact

Victor Priego, MD

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Cancer Care Specialists, Reno, Nevada

Status

Recruiting

Address

Cancer Care Specialists

Reno, Nevada, 89511

Site Contact

Subramanyeswara Arekapudi, MD

ptgxclintrials@ptgx-inc.com

1-888-899-1543

Gabrail Cancer Center, Canton, Ohio

Status

Recruiting

Address

Gabrail Cancer Center

Canton, Ohio, 44718

Site Contact

Nashat Gabrail, MD

ptgxclintrials@ptgx-inc.com

1-888-899-1543

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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