Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2007-006218-40-BG
EUCTR2007-006218-40-BGActive, not recruitingNot 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 Infection

ovartis Pharma Services AG0 sites28 target enrollmentStarted: December 3, 2009Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
28
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Subjects or legal guardian must have read and signed the written informed consent form (ICF) after the nature of the study has been fully axplained and all questions answered.
  • •Subjects must be between the ages of 2 to 18 years with body weight within 15% of normal relative to age, based on either the Centers for Disease Control and Prevention (CDC) growth chart or national health service norms.
  • •The subject must have documented HBV infection with both:
  • •- Positive HBsAg assay at screening;
  • •- Positive serum HBV DNA at Screening
  • •Subjects must have a screening creatinine clearance (CLcr) =80mL/min/1.73m2 as estimated by the schwrtz formula (See Section 8.2.2.1).
  • •All female subjects of reproductive potential must have negative serum pregnancy test at screening and negative urine pregnancy test on day 1.
  • •All subjects of reproductive potential must agree to use appropriate barrier method of birth control or agree to abstain from intercourse from day 1 through day 30 after dosing.
  • •Subjects must agree not to take any other medications during the course of the study, without the approval of the Investigator, who in consultation with the Sponsor, may permit its use, on a case-by-case basis, when it is judged not to jeopardize the subject’s safety or interfere with study endpoints.
  • •Subjects must agree not to consume alcohol within two days of reporting to the clinic on day 1.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •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).
  • •Subjects with a positive screening result for hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV type 1 or 2.
  • •Other clinically significant disease, condition or abnormality, unrelated to their HBV infection, as assessed by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory testing, including:
  • •- Hemoglobin value<110g/L (11.0g/dL) for males and<100g/L (10.0g/dL) for females;
  • •- Absolute neutrophil count (ANC)<1,500/mm3;
  • •- Platelet count<120,000/mm3;
  • •- White blood cell count (WBC)<3×109/L (<3,000/mm3);
  • •- Prothrombin time prolonged by more than 3 seconds, based on the Upper Limit Normal (ULN); of the reference value);
  • •- Serum amylase or lipase=1.5×ULN;
  • •- Serum albumin<3.5g/dL;
  • •- Total bilirubin=2.0mg/dL;
  • •- AFP>50ng/mL;
  • •- Serum ALT level>10×ULN;
  • •- Blood urea nitrogen (BUN) within normal limits.
  • •Participation in clinical drug study within 30 days of screening.
  • •Treatment with interferon within six months of screening.
  • •Treatment with nucleoside/nucleotide reverse transcriptase inhibitors within three months od screening.
  • •Treatment with any other anti-HBV drugs or other antiviral therapy (e.g. acyclovir, ganciclovir) within 30 days of study drug dosing.
  • •Treatment with antibiotics within 30 days of screening.
  • •Females who are pregnant or are breat-feeding.
  • •Subjects who are currently abusing alcohol or illicit drugs, or have a history of such abuse within the preceding two years. For the purposes of the present study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40g of alcohol.

Investigators

Similar Trials

Active, not recruiting
Phase 1
A study to evaluate the processing by the body and safety of pralsetinib in participants with hepatic impairment compared to healthy participantsHepatic impairmentDigestive System
ISRCTN38890848Roche (United States)32
Active, not recruiting
Phase 1
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 InfectioChronic hepatitis BMedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
EUCTR2007-006218-40-GBovartis Pharma Services AG23
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 InfectioChronic hepatitis BMedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
EUCTR2007-006218-40-DEovartis Pharma Services AG28
Active, not recruiting
Phase 1
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 InfectioChronic hepatitis BMedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
EUCTR2007-006218-40-BEovartis Pharma Services AG28
Completed
Phase 1
Open-Label, Single Dose Study to Evaluate the Safety and Efficacy of Nivolumab With or Without GS 4774 for the Treatment of Chronic Hepatitis B patients who are currently receiving oral antiviral treatment
ACTRN12615001133527Gilead Sciences, Inc.24
A phase I, Open-Label, Single-Dose Study... | Clinical Trial