Polycythemia VeraPhase 2PACIFICNCT04767802
PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit
A Phase 2 study testing PTG-300 in people with Polycythemia Vera, run by Protagonist Therapeutics, Inc. at 8 sites in 2 countries.
Trial summary
This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit >48% prior to dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- PTG-300
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 2 Feb 2021to 15 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known diagnosis of polycythemia vera.
- Hematocrit >48% before dosing.
- Evidence of hematocrit >48% three or more times in the 28 weeks before dosing or five or more times in 52 weeks before dosing (except for newly diagnosed patients).
- Clinically reasonable alternative causes for erythrocytosis have been evaluated and excluded.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Who cannot join
- Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 3 months of Screening.
- Active or chronic bleeding within 4 weeks of Screening.
- Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
- Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infection requiring systemic antimicrobial therapy within 4 weeks of dosing. Prophylactic antibiotics are allowed.
- Any serious or unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from properly providing informed consent or any condition which would jeopardize compliance with the study.
- Known primary or secondary immunodeficiency.
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- Known positive for active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- Any surgical procedure requiring general anesthesia within 1 month prior to Screening or planned elective surgery during the study.
- History of invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized curatively treated prostate cancer or cervical cancer.
- Current or recent history of alcohol dependence or illicit drug use within 1 year prior to Screening.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Malaysia5 sites
Hospital Ampang
Ampang, Selangor
Hospital Raja Permaisuki Bainun
Ipoh, Perak
Hospital Sultanah Aminah
Johor Bahru, Johor
Hospital Raja Perempuan Zainab
Kota Bharu, Kelantan
Hospital Umum Sarawak
Kuching, Sarawak
South Korea3 sites
Gachon University Medical Center
Incheon
Seoul National University Hospital
Seoul
Seoul St. Mary's Catholic University Hospital
Seoul
About this study
Official title: A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit (PACIFIC)
This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit >48% prior to dosing. The PTG-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit <45% with a target of <43%. Subjects may receive PTG-300 treatment for up to 52 weeks.
- Conditions
- Polycythemia Vera
- Being tested
- PTG-300
- Keywords
- PV
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTG-300Drug
Also called Rusfertide
Hepcidin mimetic
| Study group | Role | What they receive |
|---|---|---|
| PTG-300 | Experimental | Evaluate PTG-300's efficacy and safety in subjects with PV and baseline elevated hematocrit. Receives: Drug: PTG-300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit.
Proportion of subjects with hematocrit <45%
Measured: Estimate the proportion of subject with a hematocrit less than 45% at Week 16
Secondary outcomes (1)
Safety of PTG-300
Proportion of Subjects Treatment-Emergent Adverse Events
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start2 Feb 2021
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protagonist Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767802
- Sponsor's protocol ID
- PTG-300-08
- Acronym
- PACIFIC
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit (PACIFIC)
- ClinicalTrials.gov ID
- NCT04767802
- Acronym / sponsor ID
- PACIFIC / PTG-300-08
- Conditions
- Polycythemia Vera
- Keywords
- PV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Protagonist Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit >48% prior to dosing. The PTG-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit <45% with a target of <43%. Subjects may receive PTG-300 treatment for up to 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTG-300 | Experimental | Drug: PTG-300Evaluate PTG-300's efficacy and safety in subjects with PV and baseline elevated hematocrit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Known diagnosis of polycythemia vera.
- Hematocrit >48% before dosing.
- Evidence of hematocrit >48% three or more times in the 28 weeks before dosing or five or more times in 52 weeks before dosing (except for newly diagnosed patients).
- Clinically reasonable alternative causes for erythrocytosis have been evaluated and excluded.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Key exclusion criteria (10 listed)
- Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 3 months of Screening.
- Active or chronic bleeding within 4 weeks of Screening.
- Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
- Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infection requiring systemic antimicrobial therapy within 4 weeks of dosing. Prophylactic antibiotics are allowed.
- Any serious or unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from properly providing informed consent or any condition which would jeopardize compliance with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTG-300Also: RusfertideHepcidin mimetic | Drug | PTG-300 |
Primary outcome
Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit.
Time frame: Estimate the proportion of subject with a hematocrit less than 45% at Week 16
Proportion of subjects with hematocrit <45%
1 secondary outcome
Safety of PTG-300
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTG-300 in people with Polycythemia Vera, run by Protagonist Therapeutics, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Malaysia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit. (time frame: Estimate the proportion of subject with a hematocrit less than 45% at Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.