Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hemophilic Arthropathy

In brief

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.

Key facts

Study ID

NCT04684511

Run by

Tremeau Pharmceuticals, Inc.

People needed

2

Starts

2021-06-02

Expected to finish

2022-09-28

Last updated by the study team

2022-10-27

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center — Los Angeles, California, United States
• Center for Inherited Blood Disorders — Orange, California, United States
• UC Davis Children's Hospital — Sacramento, California, United States
• University of Colorado Hemophilia & Thrombosis Center — Aurora, Colorado, United States
• Georgetown University Hospital - Medstar — Washington D.C., District of Columbia, United States
• University of Florida - Shands — Gainesville, Florida, United States
• Clinical Trial Services, Corp — Miami, Florida, United States
• Anchor Medical Research, LLC — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Louisiana Center for Bleeding and Clotting Disorders — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• ECMC Hospital — Buffalo, New York, United States
• Icahn School of Medicine at Mount Sinai. — New York, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• North Texas Comprehensive Hemophilia Center — Dallas, Texas, United States
• Gulf States Hemophilia and Thrombophilia Center — Houston, Texas, United States
• Calvary Mater Newcastle — Waratah, New South Wales, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• The Alfred Hospital — Melbourne, Australia
• Health Sciences Center — St. John's, Newfoundland and Labrador, Canada
• Hamilton Health Sciences Centre — Hamilton, Ontario, Canada
• Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi — Bologna, Italy

Full record on ClinicalTrials.gov

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