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Hepcidin Mimetic

Hepcidin Mimetic for Polycythemia Vera

Phase 2
Waitlist Available
Research Sponsored by Protagonist Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events due to cytoreductive therapy
Subjects who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events due to cytoreductive therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

Study Summary

This trial is testing a new drug, PTG-300, for people with a blood disorder called polycythemia vera. The study will see if the drug is safe and if it works.

Who is the study for?
Adults diagnosed with polycythemia vera, who've had regular phlebotomies for at least 28 weeks and are either on a stable or decreasing dose of cytoreductive therapy (like hydroxyurea, interferon, or ruxolitinib) for over 24 weeks. Those not on such therapies must have stopped them for at least 24 weeks prior.Check my eligibility
What is being tested?
The trial is testing PTG-300, a hepcidin mimetic against a placebo in patients requiring frequent blood withdrawals due to polycythemia vera. It includes an initial phase where everyone gets PTG-300 to find the best dose followed by a blind test where neither doctors nor patients know who's getting what.See study design
What are the potential side effects?
While specific side effects of PTG-300 aren't listed here, similar treatments may cause issues like injection site reactions, fatigue, joint pain or swelling. The study aims to monitor safety closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I stopped any previous cancer-shrinking treatments 24 weeks ago and have recovered from side effects.
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I stopped any previous cancer-shrinking treatments 24 weeks ago and have recovered from side effects.
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I stopped any previous cancer-shrinking treatments 24 weeks ago and have recovered from side effects.
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I'm sorry, I cannot provide a summary for "Main" as it does not provide any context or information about what is being referred to. Can you please provide more details?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of responders during the blinded randomized withdrawal period (Week 29 to Week 41).
Secondary outcome measures
Venous blood sampling
Change in rate of phlebotomy events between Week 17 through Week 29 (inclusive; 12 weeks) compared to each subject's historical rate.
Proportion of subjects achieving a response at Week 29, with response defined as having achieved the absence of "phlebotomy eligibility" during the efficacy evaluation phase beginning at Week 17 and continuing to Week 29.
+1 more

Side effects data

From 2022 Phase 2 trial • 16 Patients • NCT04202965
31%
Injection site pain
19%
Injection site pruritus
13%
Diarrhea
13%
Injection site erythema
13%
Fatigue
13%
Headache
13%
Dizziness
13%
Hypertension
6%
Cellulitis
6%
Back pain
6%
Supraventricular extrasystoles
6%
Melanocytic naevus
6%
Adenocarcinoma pancreas
6%
Inflammation
6%
Vomiting
6%
Gastrointestinal bacterial overgrowth
6%
Injection site bruising
6%
Injection site swelling
6%
Injection site induration
6%
Injection site haemorrhage
6%
Dry mouth
6%
Nausea
6%
Malaise
6%
Injection site discomfort
6%
Hand fracture
6%
Injection site haematoma
6%
Rash
6%
Paraesthesia
6%
Insomnia
6%
Bronchospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
PTG-300

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose finding PTG-300 (Part 1); Placebo (Part 2); Open label extension PTG-300 (Part 3)Experimental Treatment2 Interventions
Group II: Dose finding PTG-300 (Part 1); PTG-300 (Part 2); Open label extension PTG-300 (Part 3)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PTG-300
2019
Completed Phase 2
~150
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Protagonist Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
879 Total Patients Enrolled
3 Trials studying Polycythemia Vera
320 Patients Enrolled for Polycythemia Vera

Media Library

PTG-300 (Hepcidin Mimetic) Clinical Trial Eligibility Overview. Trial Name: NCT04057040 — Phase 2
Polycythemia Vera Research Study Groups: Dose finding PTG-300 (Part 1); PTG-300 (Part 2); Open label extension PTG-300 (Part 3), Dose finding PTG-300 (Part 1); Placebo (Part 2); Open label extension PTG-300 (Part 3)
Polycythemia Vera Clinical Trial 2023: PTG-300 Highlights & Side Effects. Trial Name: NCT04057040 — Phase 2
PTG-300 (Hepcidin Mimetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04057040 — Phase 2
Polycythemia Vera Patient Testimony for trial: Trial Name: NCT04057040 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites have been chosen to host this clinical investigation?

"Currently, this medical trial is enrolling patients from 10 different sites across the USA. These include Phoenix, Detroit and Palo Alto in addition to other cities. It may be beneficial for participants to select a clinic near them to reduce travel requirements."

Answered by AI

Has PTG-300 been sanctioned by the Food and Drug Administration?

"Our team at Power determined the relative safety of PTG-300 to be a 2, as there is only limited clinical evidence regarding its efficacy. Nonetheless, multiple studies have been conducted that confirm its safety profile."

Answered by AI

Are there any remaining places in this clinical research program available for participants?

"As per the data on clinicaltrials.gov, this medical trial is not seeking participants at this moment in time. Established on October 1st 2019 and last updated April 12th 2022, no patients can join currently; however there are 55 other studies with open recruitment."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
Other
Michigan
How old are they?
18 - 65
What site did they apply to?
Karmanos Cancer Center
Other
Stanford University
Center for Cancer and Blood Disorders
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Been on hydrea and regular phlebs for many years.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)
2019. "Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04057040.
All > Polycythemia Vera
~19 spots leftby Oct 2025
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