Overview

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