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Clinical Trials/EUCTR2007-006218-40-Outside-EU/EEA
EUCTR2007-006218-40-Outside-EU/EEA
Active, not recruiting
Not Applicable

A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LdT) in Children and Adolescents with Chronic Hepatitis B Virus InfectionEMA decision numbers on this PIP:P/111/2008, P/119/2010, P/203/2011

ovartis Pharma Services AG0 sites28 target enrollmentMarch 9, 2012
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DrugsSebivo

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma Services AG
Enrollment
28
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 9, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Children and adolescents patients
  • •HBsAg seropositive
  • •Other protocol\-defined inclusion/exclusion criteria may apply.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 28
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Decompensated liver disease (Child\-Turcotte\-Pugh (CTP) Score\=7, Class B and C)
  • •Prior anti\-HBV therapy within 30 days of study drug dosing.
  • •Other protocol\-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Not specified

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