Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2007-006218-40-GB
EUCTR2007-006218-40-GBActive, not recruitingPhase 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 Infection

ovartis Pharma Services AG0 sites23 target enrollmentStarted: November 5, 2008Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
23
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •?1 ?Patients or legal guardian must have read and signed the written informed consent form (ICF) after the nature of the study has been fully explained and all questions answered.
  • •2 Patients must be between the ages of 2 to 18 years with body weight within 15th to 85th percentile of normal relative to age, based on either the Centers for Disease Control and Prevention (CDC) growth chart (Appendix 1) or national health service norms.
  • •3 The patient must have documented chronic HBV (CHB) infection with positive HBsAg
  • •assay at Screening.
  • •4 Patients must have a screening creatinine clearance (CLcr) = 80 mL/min/1.73 m2 as estimated by the Schwartz formula (See Section 8.2.2.1).
  • •5 All female patients of reproductive potential must have negative serum pregnancy test at Screening and negative urine pregnancy test on Day –1.
  • •6 All patients of reproductive potential must agree to use appropriate double barrier method of birth control or agree to abstain from intercourse from Day –1 through Day 30 after dosing.
  • •7 Patients 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 patient’s safety or interfere with study endpoints.
  • •8 Patients 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

  • •1 Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score=7, Class B and C)
  • •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 <110 g/L (11.0 g/dL) for males and <100 g/L (10.0 g/dL) for
  • •Absolute neutrophil count (ANC) (<1,500/ x 10E3) (<1.5x10E9)
  • •Platelet count (< 120,000/ x10E3) (<120 x10E9)
  • •White blood cell count (WBC) (<3,000/ x10E3) (3.0 x10E9)
  • •Prothrombin time/INR prolonged by more than 3 seconds, (based on the Upper Limit Normal [ULN]; of the reference value)
  • •Serum amylase or lipase =1.5 x ULN;
  • •Serum albumin (<3.5 g/dL); (<35 g/L)
  • •Total bilirubin (=2.0 mg/dL or =34.2 µmol/L);
  • •Serum ALT level >10 x ULN.
  • •Blood urea nitrogen (BUN) greater than the upper limit of normal.
  • •3 Participation in a clinical drug study within 30 days of Screening.
  • •4 Treatment with interferon within six months of Screening.
  • •5 Treatment with nucleoside/nucleotide reverse transcriptase inhibitors within three months of Screening.
  • •6 Treatment with any other anti-HBV drugs or other antiviral therapy (e.g., acyclovir
  • •ganciclovir) within 30 days of study drug dosing.
  • •7 Treatment with antibiotics within 7 days of Screening.
  • •8 Females who are pregnant or are breast-feeding.
  • •9 Patients 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 40 g 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
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
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-BGovartis 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