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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR NALFURAFINE

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Clinical Trials for Nalfurafine

Trial ID Title Status Sponsor Phase Summary
NCT00638495 Phase II Study of TRK-820 Soft Capsules — Intractable Pruritus in Patients With Chronic Liver Disease — Completed Toray Industries, Inc Phase 2 The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.
NCT00793156 A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch) Unknown status Acologix, Inc. Phase 3 Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.
NCT01248650 Safety Study of TRK-820 for Patient With Hemodialysis Completed Toray Industries, Inc Phase 1 The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Nalfurafine

Condition Name

Condition Name for
Intervention Trials
Uremic Pruritus 3
Pruritus With Chronic Liver Disease 1
Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Pruritus 5
Kidney Failure, Chronic 2
Kidney Diseases 1
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Clinical Trial Locations for Nalfurafine

Trials by Country

Trials by Country for
Location Trials
United States 3
Korea, Republic of 2
Germany 1
Japan 1
Bulgaria 1
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Trials by US State

Trials by US State for
Location Trials
Texas 1
New York 1
California 1
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Clinical Trial Progress for Nalfurafine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 2
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 3
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for Nalfurafine

Sponsor Name

Sponsor Name for
Sponsor Trials
Toray Industries, Inc 5
SK Chemicals Co.,Ltd. 2
Acologix, Inc. 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 8
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