WHO ICTRP trial

A Phase 2b study for adults hospitalized with Respiratory Syncytial Virus.

EUCTR2016-001653-40-GB · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2016-001653-40-GB
Public title A Phase 2b study for adults hospitalized with Respiratory Syncytial Virus.
Scientific title A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus - A Phase 2b study for adults…
Primary sponsor Janssen-Cilag International NV
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Taiwan;Spain;United Kingdom;France;Mexico;Canada;Argentina;Poland;Malaysia;Belgium;Brazil;Singapore;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of;Sweden
Conditions Respiratory Syncytial Virus Infection MedDRA version: 20.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Virus…
Interventions Product Name: ALS-008176 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Lumicitabine CAS Number: 1445385-02-3 Current Sponsor code: ALS-008176 Other descriptive name: JNJ-64041575-AAA Concentration unit: mg milligram(s)…
Registration date Jun 28, 2016
Target size 218
Secondary IDs 64041575RSV2003
Registry page clinicaltrialsregister.eu

At a glance

  • Yes Results available

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