WHO ICTRP trial

Evaluation of preventive efficacy of valaciclovir hydrochloride in herpes…

EUCTR2015-004869-88-Outside-EU/EEA · EU Clinical Trials Register

Key facts

Trial ID EUCTR2015-004869-88-Outside-EU/EEA
Public title Evaluation of preventive efficacy of valaciclovir hydrochloride in herpes simplex virus infection for hematopoietic stem cell transplantation patients.
Scientific title A multicenter, open-label study to evaluate preventive efficacy for herpes simplex virus infection and safety of 256U87 (valaciclovir hydrochloride) in adult and pediatric hematopoietic stem cell transplantation patients.
Primary sponsor GlaxoSmithKline K.K. (GSK)
Registry EU Clinical Trials Register
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Japan
Conditions Herpes simplex virus (HSV) infection before and after hematopoietic stem cell transplantation.;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Interventions Trade Name: Valtrex Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VALACICLOVIR HYDROCHLORIDE Other descriptive name: VALACICLOVIR HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration…
Registration date Dec 21, 2016
Target size 40
Secondary IDs HS2116100
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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