50 Participants Needed

Rusfertide for Polycythemia Vera

(THRIVE Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Protagonist Therapeutics, Inc.
Must be taking: Rusfertide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use other investigational treatments during the study or within 28 days after the last rusfertide dose.

How is the drug rusfertide unique for treating polycythemia vera?

Rusfertide is unique because it is a novel treatment specifically designed to manage polycythemia vera, a condition with limited standard treatment options. It works by reducing the production of red blood cells, which is different from other treatments that may focus on managing symptoms or complications.12345

Eligibility Criteria

This trial is for people with Polycythemia Vera who have already been treated with rusfertide for at least 12 months in a previous Phase 2 or Phase 3 study. Participants must understand the study, be willing to follow its rules, and give written consent.

Inclusion Criteria

I completed a year of rusfertide treatment and finished the final visit of a prior study.
I understand the study, can follow its requirements, and agree to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue treatment with rusfertide to assess long-term safety and efficacy

0-2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Open-label rusfertide
Trial Overview The trial is testing the long-term safety and effectiveness of an open-label drug called rusfertide in patients with Polycythemia Vera. It's an extension for those who've completed prior rusfertide studies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open-label rusfertideExperimental Treatment1 Intervention
Open-label rusfertide

Find a Clinic Near You

Who Is Running the Clinical Trial?

Protagonist Therapeutics, Inc.

Lead Sponsor

Trials
13
Recruited
960+

Findings from Research

In a study of 45 ATG-naïve patients with aplastic anemia, 62% achieved a hematologic response after 6 months of treatment with thrombopoietin receptor agonists (TPO-RAs), demonstrating their efficacy in this patient group.
Eltrombopag, a type of TPO-RA, was effective even in elderly patients with severe aplastic anemia who were ineligible for anti-thymocyte globulin (ATG) treatment, suggesting it is a viable alternative for those with age-related or health-related treatment restrictions.
Real-world experience of treatment with thrombopoietin receptor agonists in anti-thymocyte globulin-naïve patients with aplastic anemia: an observational retrospective analysis in a single institution.Iino, M., Jinguji, A., Sato, T., et al.[2022]
Eltrombopag's bioavailability is significantly reduced (by 59% for AUC and 65% for Cmax) when taken with a high-fat, high-calcium breakfast compared to a fasted state, indicating that food can greatly affect its absorption.
In contrast, low-calcium meals do not significantly alter eltrombopag's bioavailability, but taking it with an antacid containing aluminum and magnesium can decrease its systemic exposure by approximately 70%. Overall, eltrombopag was well tolerated with mild to moderate side effects reported.
Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies.Williams, DD., Peng, B., Bailey, CK., et al.[2016]

References

[Impact of recombinant human thrombopoietin (rhTPO) on short-term response of immunosuppressive therapy in patients with newly diagnosed acquired severe aplastic anemia]. [2023]
Real-world experience of treatment with thrombopoietin receptor agonists in anti-thymocyte globulin-naïve patients with aplastic anemia: an observational retrospective analysis in a single institution. [2022]
Recombinant human thrombopoietin treatment promotes hematopoiesis recovery in patients with severe aplastic anemia receiving immunosuppressive therapy. [2021]
Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies. [2016]
Comparison of up-front treatments for newly diagnosed immune thrombocytopenia -a systematic review and network meta-analysis. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security