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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006283
Receipt No. R000007437
Scientific Title The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis
Date of disclosure of the study information 2016/12/31
Last modified on 2014/09/05

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Basic information
Public title The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis
Acronym CHALLENGE D trial
Scientific Title The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis
Scientific Title:Acronym CHALLENGE D trial
Region
Japan

Condition
Condition Hepatitis C virus-related compensated cirrhosis with osteoporosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of efficacy and safety of administration of Eldecalcitol with the Peginterferon alpha 2a/Ribavirin therapy to hepatitis C virus-related compensated cirrhosis patients with osteoporosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained Virological Response ( SVR )
Key secondary outcomes ALT normalization
Safety

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 Peginterferon alpha 2a
Ribavirin
Eldecalcitol
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The following hepatitis C virus-related compensated cirrhosis patients were eligible to enter the trial
Osteoporosis
patients to whom it was confirmed that there was no hepatocellular carcinoma by imaging test (CT or MRI)
WBC counts>=3,000/microL
Neutrophil counts>=1,500/microL
Hemoglobin concentration>=12g/dL
Platelet counts>=75,000/microL
patients who provided written informed consent to participate the study prior to enrollment
Key exclusion criteria The following patients were excluded
women of childbearing potential and pregnancy, lactating women
allergic to ribavirin or other nucleoside analoges
an uncontrollable heart trouble( myocardial infarction, heart failure, or arrhythmia)
hemoglobibopathy ( thalassemia, sickle cell disease)
severe renal disease or Ccr<50mL/min
severe depression or psychosomatic disorders
severe liver disease
autoimmune hepatitis or HBV
drug allegy against interferon
allergic to vaccine or biological preperations
concomitant herbal medication of Sho-saiko-to
history of interstitial pneumonia
patients who take active vitamin D3 other than Eldecalcitol
other conditions considerd
inappropriate by attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Tamori
Organization Osaka City University, Graduate School of Medicine
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3811
Email atamori@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Tamori
Organization Osaka City University, Graduate School of Medicine
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL 06-6645-3811
Homepage URL
Email kantansuinaika@med.osaka-cu.ac.jp

Sponsor
Institute Department of Hepatology, Osaka City University
Institute
Department

Funding Source
Organization Osaka City University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
It is difficult to enroll the enough patients with cirrhosis from now on. We decide that the present study is closed. 
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 Terminated
Date of protocol fixation
2011 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 31 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 09 Month 05 Day
Last modified on
2014 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007437

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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