Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

Hemophilic Arthropathy Clinical Trial

— RESET-HA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04684511
• Other study ID #: TRM-201-HA-301
• Status: Terminated
• Phase: Phase 3
• Start date: June 2, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: August 2022
• Source: Tremeau Pharmceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 safety and maintenance of efficacy of TRM-201.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Hemophilic Arthropathy
• Joint Diseases

Intervention

Drug:
• TRM-201 (Rofecoxib)
Eligible patients will be randomized to receive TRM-201 or placebo
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Health Sciences Center	Saint John's	Newfoundland and Labrador
Italy	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi	Bologna
Italy	Ospedale Pediatrico Bambino Gesù	Roma
Poland	Centrum Medyczne Pratia Poznan	Poznan
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Turkey	Acibadem Adana Hospital	Adana
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Erciyes University Medical Faculty	Edirne
Turkey	Gaziantep University Medical Faculty Sahinbey Educational Research Hospital	Gaziantep
Turkey	Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Ege University Medical Faculty	Izmir
Turkey	Ondokuz Mayis Univ. Med. Fac.	Samsun
Ukraine	CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC	Dnipro
Ukraine	CI of Healthcare Kharkiv City Clin Children's Hosp #16 Kharkiv NMU	Kharkiv
Ukraine	Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Kyiv CCH #9 City SPC of Diagnostics & Treatment of Patients with HP	Kyiv
Ukraine	Nat.Children Specialized Hosp.OKHMATDYT of the Ministry of Health of Ukraine	Kyiv
Ukraine	SI Institute of Blood Pathology and Transfusion Medicine of NAMSU	Lviv
Ukraine	M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy	Poltava
Ukraine	CI of TRC Ternopil UH	Ternopil'
Ukraine	CI Zaporizhzhya Regional Clinical Hospital of ZRC	Zaporizhzhya
United States	University of Colorado Hemophilia & Thrombosis Center	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	ECMC Hospital	Buffalo	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	North Texas Comprehensive Hemophilia Center	Dallas	Texas
United States	University of Florida - Shands	Gainesville	Florida
United States	East Carolina University	Greenville	North Carolina
United States	Gulf States Hemophilia and Thrombophilia Center	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center	Los Angeles	California
United States	Anchor Medical Research, LLC	Miami	Florida
United States	Clinical Trial Services, Corp	Miami	Florida
United States	Louisiana Center for Bleeding and Clotting Disorders	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai.	New York	New York
United States	Center for Inherited Blood Disorders	Orange	California
United States	Oregon Health & Science University	Portland	Oregon
United States	UC Davis Children's Hospital	Sacramento	California
United States	Georgetown University Hospital - Medstar	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Tremeau Pharmceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy,  Poland,  Spain,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks