Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tremeau Pharmceuticals, Inc.
• Treatments: Rofecoxib

Criteria

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