Hemophilic ArthropathyPhase 3RESET-HANCT04684511
Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
A Phase 3 study testing TRM-201 (Rofecoxib) in people with Hemophilic Arthropathy, run by Tremeau Pharmceuticals, Inc. at 46 sites in 8 countries.
Trial summary
This is a multicenter, randomized, double-blind study to evaluate the efficacy and safety of TRM-201 (rofecoxib) versus Placebo in the treatment of patients with hemophilic arthropathy (HA) over a 12-week period (Part I) that is followed by a year-long (52 week) open-label extension (Part II) to further evaluate the… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hemophilic Arthropathy
- What is being tested?
- TRM-201 (Rofecoxib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 46 sitesin 8 countries
- Study dates
- 2 Jun 2021to 28 Sep 2022
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of hemophilia A or B
- Either on a stable prophylaxis regimen for their bleeding disorder (factor, bypassing agent, or nonfactor product therapy) OR currently taking or agree to initiate a gastroprotective agent (esomeprazole) for the duration of the trial
- Diagnosis of Hemophilic Arthopathy for at least 6 months prior to screening
- Chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening.
- Able and willing to wash out of non-study analgesic medications/agents for at least 7 days prior to Randomization including: acetaminophen (paracetamol), NSAIDs, opioids, cannabinoids, topical analgesics, benzodiazepines, gabapentin/pregabalin-containing products and other antiepileptic drugs used for pain
- Primary source of pain is due to Hemophilic Arthropathy
Who cannot join
- Taking opioids for greater than 4 days per week prior to screening
- Has a history of advanced renal disease or severe liver disease (within the last 6 months)
- Receiving emicizumab while also receiving activated prothrombin complex concentrate (FEIBA)
- Uncontrolled or poorly controlled hypertension
- History of major cardiac or cerebrovascular disease
- History of an upper GI perforation, obstruction, or major GI bleed or current evidence of GI bleeding
Show all 9Show fewer
- Has active hepatitis C or hepatitis B infection or uncontrolled HIV. Note: Patients who are HIV positive are allowed to participate if considered to be controlled.
- Has a positive drug screen for all prohibited drugs of potential abuse at screening
- Has had an intra-articular injection (within 3 months), initiated physical therapy (within 30 days) or has had orthopedic surgery (within 4 months) prior to screening
Trial locations and contacts
46 sites in 8 countries.
46 sites in 8 countries
United States19 sites
University of Colorado Hemophilia & Thrombosis Center
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21205
ECMC Hospital
Buffalo, New York, 14202
Rush University Medical Center
Chicago, Illinois, 60612
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
North Texas Comprehensive Hemophilia Center
Dallas, Texas, 75390
University of Florida - Shands
Gainesville, Florida, 32610
East Carolina University
Greenville, North Carolina, 27858
Gulf States Hemophilia and Thrombophilia Center
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center
Los Angeles, California, 90007
Clinical Trial Services, Corp
Miami, Florida, 33144
Anchor Medical Research, LLC
Miami, Florida, 33176
Louisiana Center for Bleeding and Clotting Disorders
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai.
New York, New York, 10029
Center for Inherited Blood Disorders
Orange, California, 92868
Oregon Health & Science University
Portland, Oregon, 97239
UC Davis Children's Hospital
Sacramento, California, 95817
Georgetown University Hospital - Medstar
Washington D.C., District of Columbia, 20007
Ukraine9 sites
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC
Dnipro
CI of Healthcare Kharkiv City Clin Children's Hosp #16 Kharkiv NMU
Kharkiv
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv
Kyiv CCH #9 City SPC of Diagnostics & Treatment of Patients with HP
Kyiv
Nat.Children Specialized Hosp.OKHMATDYT of the Ministry of Health of Ukraine
Kyiv
SI Institute of Blood Pathology and Transfusion Medicine of NAMSU
Lviv
M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
Poltava
CI of TRC Ternopil UH
Ternopil
CI Zaporizhzhya Regional Clinical Hospital of ZRC
Zaporizhzhya
Turkey (Türkiye)8 sites
Acibadem Adana Hospital
Adana
Akdeniz University Medical Faculty
Antalya
Erciyes University Medical Faculty
Edirne
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep, 27310
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul
Ege University Medical Faculty
Izmir, 35100
Ege University Medical Faculty
Izmir
Ondokuz Mayis Univ. Med. Fac.
Samsun
Australia3 sites
The Alfred Hospital
Melbourne, 3004
Fiona Stanley Hospital
Murdoch, Western Australia
Calvary Mater Newcastle
Waratah, New South Wales
Canada2 sites
Hamilton Health Sciences Centre
Hamilton, Ontario
Health Sciences Center
St. John's, Newfoundland and Labrador, NL A1B3V6
Italy2 sites
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna
Ospedale Pediatrico Bambino Gesù
Roma
Poland2 sites
Centrum Medyczne Pratia Poznan
Poznan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw
Spain1 site
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study With a Long-Term, Open-Label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients With Hemophilic Arthropathy
This is a multicenter, randomized, double-blind study to evaluate the efficacy and safety of TRM-201 (rofecoxib) versus Placebo in the treatment of patients with hemophilic arthropathy (HA) over a 12-week period (Part I) that is followed by a year-long (52 week) open-label extension (Part II) to further evaluate the safety and maintenance of efficacy of TRM-201.
- Conditions
- Hemophilic Arthropathy
- Being tested
- TRM-201 (Rofecoxib), Placebo
- Keywords
- Hemophilia, Pain, HA, Joint Pain
- Medical subject headings
- Hemophilia A, Pain, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRM-201 (Rofecoxib)Drug
Also called Placebo
Eligible patients will be randomized to receive TRM-201 or placebo
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| TRM-201 (Rofecoxib) | Experimental | 1 TRM-201 tablet taken orally once daily for 12 weeks in Part I and orally once daily for an additional 52 weeks in Part II Receives: Drug: TRM-201 (Rofecoxib) |
| Placebo | Placebo comparator | 1 placebo tablet (to match TRM-201) taken orally once daily for 12 weeks in Part I and then 1 TRM-201 tablet taken orally once daily for an additional 52 weeks in Part II Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the patient assessment of the daily Average Hemophilic arthropathy Pain Intensity score on a 0- to 10-point numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start2 Jun 2021
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Why it stopped: Low enrollment. The termination of the trial was not based on any safety concerns in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilic ArthropathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tremeau Pharmceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judith Boice, PhD, Study director, Tremeau Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684511
- Sponsor's protocol ID
- TRM-201-HA-301
- Acronym
- RESET-HA
- Status last verified
- Aug 2022
- First submitted
- 21 Dec 2020
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study With a Long-Term, Open-Label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients With Hemophilic Arthropathy
- ClinicalTrials.gov ID
- NCT04684511
- Acronym / sponsor ID
- RESET-HA / TRM-201-HA-301
- Conditions
- Hemophilic Arthropathy
- Keywords
- Hemophilia, Pain, HA, Joint Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment. The termination of the trial was not based on any safety concerns in the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tremeau Pharmceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 24 Dec 2020 (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 a multicenter, randomized, double-blind study to evaluate the efficacy and safety of TRM-201 (rofecoxib) versus Placebo in the treatment of patients with hemophilic arthropathy (HA) over a 12-week period (Part I) that is followed by a year-long (52 week) open-label extension (Part II) to further evaluate the safety and maintenance of efficacy of TRM-201.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRM-201 (Rofecoxib) | Experimental | Drug: TRM-201 (Rofecoxib)1 TRM-201 tablet taken orally once daily for 12 weeks in Part I and orally once daily for an additional 52 weeks in Part II |
| Placebo | Placebo comparator | Drug: Placebo1 placebo tablet (to match TRM-201) taken orally once daily for 12 weeks in Part I and then 1 TRM-201 tablet taken orally once daily for an additional 52 weeks in Part II |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of hemophilia A or B
- Either on a stable prophylaxis regimen for their bleeding disorder (factor, bypassing agent, or nonfactor product therapy) OR currently taking or agree to initiate a gastroprotective agent (esomeprazole) for the duration of the trial
- Diagnosis of Hemophilic Arthopathy for at least 6 months prior to screening
- Chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening.
- Able and willing to wash out of non-study analgesic medications/agents for at least 7 days prior to Randomization including: acetaminophen (paracetamol), NSAIDs, opioids, cannabinoids, topical analgesics, benzodiazepines, gabapentin/pregabalin-containing products and other antiepileptic drugs used for pain
Key exclusion criteria (9 listed)
- Taking opioids for greater than 4 days per week prior to screening
- Has a history of advanced renal disease or severe liver disease (within the last 6 months)
- Receiving emicizumab while also receiving activated prothrombin complex concentrate (FEIBA)
- Uncontrolled or poorly controlled hypertension
- History of major cardiac or cerebrovascular disease
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 |
|---|---|---|
| TRM-201 (Rofecoxib)Also: PlaceboEligible patients will be randomized to receive TRM-201 or placebo | Drug | TRM-201 (Rofecoxib) |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
The change from baseline in the patient assessment of the daily Average Hemophilic arthropathy Pain Intensity score on a 0- to 10-point numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Low enrollment. The termination of the trial was not based on any safety concerns in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
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Real-World Joint Outcomes After Selective Transition to Low-Dose Emicizumab in Pediatric Hemophilia A
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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.
Judith Boice, PhD study director
Tremeau Pharmaceuticals
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRM-201 (Rofecoxib) in people with Hemophilic Arthropathy, run by Tremeau Pharmceuticals, Inc. at 46 sites in 8 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Ukraine, Turkey (Türkiye), Australia, Canada and 3 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Low enrollment. The termination of the trial was not based on any safety concerns in the study.). Results are not available in the source record.
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?
The change from baseline in the patient assessment of the daily Average Hemophilic arthropathy Pain Intensity score on a 0- to 10-point numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine. (time frame: 12 weeks). 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 27 Oct 2022.