Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

Trevi Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Uremic Pruritus; Pruritus

Treatments: Drug: nalbuphine HCl ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT02143973

2013-005626-29 (EudraCT Number)

TR02ext

Details and patient eligibility

About

The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject completed participation in the TR02 study
• Subject is currently receiving in-center hemodialysis at the time of consent

Exclusion criteria

• Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
• Subject received opiates on a daily basis during the 1 week prior to screening
• Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening
• Subject is a pregnant or lactating female

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 1 patient group

nalbuphine HCl ER

Experimental group

Description:

nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks.

Treatment:

Drug: nalbuphine HCl ER