Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2012-004942-14-GR |
Date of registration:
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04/06/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of efficacy and safety, tolerability and pharmacokinetics of telbivudine in children and adolescents with compensated chronic hepatitis B virus infection
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Scientific title:
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A randomized, double-blind, 104-weeks treatment study to evaluate the efficacy, safety, tolerability and pharmacokinetics of telbivudine oral solution and tablets in children and adolescents with compensated HBeAg-positive and negative chronic hepatitis B virus infection
P/119/2010
P/203/2011
P/236/2012 |
Date of first enrolment:
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29/07/2014 |
Target sample size:
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150 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004942-14 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Bulgaria
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Greece
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Israel
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Italy
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Korea, Republic of
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Romania
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Russian Federation
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Taiwan
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Hassan Gandjini
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Address:
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27-35, rue Victor Hugo
94853 Ivry sur Seine Cedex
France |
Telephone:
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+33380451 201 |
Email:
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Hassan.Gandjini@ppdi.com |
Affiliation:
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PPD |
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Name:
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Hassan Gandjini
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Address:
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27-35, rue Victor Hugo
94853 Ivry sur Seine Cedex
France |
Telephone:
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+33380451 201 |
Email:
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Hassan.Gandjini@ppdi.com |
Affiliation:
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PPD |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Clinical history compatible with compensated chronic hepatitis B
• Documented compensated chronic hepatitis B defined by the following:
oPositive serum HBsAg at screening and at least one other documentation of HBsAg positive at least 6 months prior to screening
oFor HBeAg positive patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level = 5 log10 copies/mL (or 20 000 IU/mL) (COBAS Taqman®) at screening ; serum ALT = 1.5×ULN and < 10×ULN (pediatric ULN) for two times during the screening period or within 6 months prior to screening
oFor HBeAg negative patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level = 4 log10 copies/mL (or 2 000 IU/mL) (COBAS Taqman®) at screening) ; serum ALT = 1.0 ×ULN and < 10×ULN (pediatric ULN) for two times during the screening period or within 12 months prior to screening
oPatients with serum ALT value not meeting the above criteria are eligible if
available liver histology report (or FibroScan assessment) indicating moderate
to severe liver inflammation or fibrosis within 12 months before screening Are the trial subjects under 18? yes Number of subjects for this age range: 150 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: •Patients with acute or chronic infection of HCV, HDV, HIV, or with acute infection of HAV, HEV, CMV, EBV, or HSV.
•Patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-CHB treatment (approved or investigational) at any time before screening
•Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy
•Patient has one or more additional known primary or secondary causes of liver disease, other than CHB; has a decompensated liver disease ; is a Liver transplant recipient or organ or bone marrow transplant recipient.
•History of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
•Patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum CK levels (=7×ULN), any muscular disease
•Patient receiving any drugs potentially associated with myopathy within 3 months prior to screening
•Any other clinical significant disease, condition or abnormality, unrelated to their HBV infection at screening, as assessed by the investigator
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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compensated HBeAg-positive and negative chronic hepatitis B virus infection MedDRA version: 17.0
Level: PT
Classification code 10008910
Term: Chronic hepatitis B
System Organ Class: 10021881 - Infections and infestations
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Intervention(s)
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Trade Name: Sebivo Product Name: Sebivo Product Code: LDT600 Pharmaceutical Form: Oral solution INN or Proposed INN: TELBIVUDINE CAS Number: 3424-98-4 Current Sponsor code: LDT600 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use
Trade Name: Sebivo Product Name: Sebivo Product Code: LDT600 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TELBIVUDINE CAS Number: 3424-98-4 Current Sponsor code: LDT600 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: - Antiviral efficacy as evaluated by the proportion of patients achieving HBV DNA< 300 copies/mL at Week 52 and Week 104 - Biochemical response at Week 24, 52 and 104 as evaluated by proportion of patients whose baseline ALTs were abnormal and subsequently normalized - Serological response at Week 24, 52 and 104 (HBeAg loss; HBeAg seroconversion and HBsAg loss and HBsAg seroconversion) - Percentage of patients achieving composite endpoints at Week 52 and 104 (HBV DNA < 300 copies/mL, ALT normalization and HBeAg seroconversion) - Cumulative rate of Virological Breakthrough at Week 52 and 104 - Presence of genotypic resistance in VB and non-responders patients at Week 24 - Safety assessments (SAEs, AEs, AESI (muscle related events), hepatic decompensation or HCC, chemistry or hematology abnormalities
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Timepoint(s) of evaluation of this end point: Week 24
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Main Objective: The primary objective of this study is to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2- < 18 years) by determining the percentage of patients achieving serum HBV DNA level of <300 copies/mL at Week 24.
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Primary end point(s): The primary objective of the study is to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2 - < 18 years) by determining the percentage of patients achieving serum HBV DNA level of <300 copies/mL at Week 24.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Weeks 24, 52, 104
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Secondary end point(s): 1.anti-viral efficacy at Week52 and Week104
2. Biochemical response (ALT normalization) at Week 24, Week 52 and Week 104
3.Serological response at Week 24, Week 52 and Week 104
4. Composite endpoint (HBV DNA undetectability, ALT normalization and HBeAg seroconversion) at Week 52 and Week 104
5. Cumulative rate of Virological Breakthrough at Week 52 and 104
6. Presence of genotypic resistance in VB and non-responders patients at Week 24 ( or who discontinued before Week 24)
7. safety endpoints (SAEs, AEs, Grade 3-4 AEs and AEs related to study drug, AESI (muscle related events), hepatic decompensation or HCC, Grade 3-4 chemistry or hematology abnormalities
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Secondary ID(s)
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2012-004942-14-GB
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CLDT600A2306
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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