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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000190
Receipt No. R000000259
Scientific Title Adefovir dipivoxil for treatment of breakthrough hepatitis caused by lamivudine-resistant mutants of hepatitis B virus.
Date of disclosure of the study information 2005/09/12
Last modified on 2015/08/13

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Basic information
Public title Adefovir dipivoxil for treatment of breakthrough hepatitis caused by lamivudine-resistant mutants of hepatitis B virus.
Acronym GLSG, 2003, ADV
Scientific Title Adefovir dipivoxil for treatment of breakthrough hepatitis caused by lamivudine-resistant mutants of hepatitis B virus.
Scientific Title:Acronym GLSG, 2003, ADV
Region
Japan

Condition
Condition Chronic hepatitis B
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of ADV against lamivudine-resistant mutants for patients with severe acute exacerbation of hepatitis caused by lamivudine-resistant mutants.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes HBV-DNA
Key secondary outcomes Serum ALT
side effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adefovir dipivoxil
10mg/day p.o.
for at least 48 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria chronic hepatitis B
Lamivudine-resistant mutants
Abnormal ALT
positive test of HBV-DNA
Key exclusion criteria Allergy to lamivudine
complication of chronic hepatitis C
coadministration of cytotoxic drugs
leucopenia
during pregnancy
severe liver dysfunction
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511
TEL 027-220-8127
Email satoken@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511
TEL 027-220-8127
Homepage URL
Email satoken@showa.gunma-u.ac.jp

Sponsor
Institute Gunma Liver Study Group
Institute
Department

Funding Source
Organization Gunma Liver Study Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2003 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2003 Year 11 Month 01 Day
Last follow-up date
2007 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2015 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000259

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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