Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy (RESET-HA)

Tremeau Pharmceuticals

Status and phase: Terminated; Phase 3

Conditions: Hemophilic Arthropathy

Treatments: Drug: Placebo; Drug: TRM-201 (Rofecoxib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04684511

TRM-201-HA-301

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

TRM-201 (Rofecoxib)

Experimental group

Description:

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

Treatment:

Drug: TRM-201 (Rofecoxib)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo