UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027717
Receipt No. R000031752
Scientific Title The investigation about bone metabolism and sarcopenia among chronic hepatitis C patients and the impacts of DAAs combination therapy.
Date of disclosure of the study information 2017/06/11
Last modified on 2018/06/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The investigation about bone metabolism and sarcopenia among chronic hepatitis C patients and the impacts of DAAs combination therapy.
Acronym The investigation about bone metabolism and sarcopenia among CHC patients and the impacts of DAAs.
Scientific Title The investigation about bone metabolism and sarcopenia among chronic hepatitis C patients and the impacts of DAAs combination therapy.
Scientific Title:Acronym The investigation about bone metabolism and sarcopenia among CHC patients and the impacts of DAAs.
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the actual situation of bone metabolism and sarcopenia among the CHC patients, and to clarify the impacts of DAAs combination therapy for CHC patients by analyzing the change of bone metabolism and sarcopenia before and after DAAs combination therapy.
Basic objectives2 Others
Basic objectives -Others To clarify the changes of bone density, biochemical markers about bone metabolism, and muscular strength among the chronic hepatitis C patients who achieved SVR after DAAs combination therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of bone density, biochemical markers about bone metabolism, and muscular strength among the chronic hepatitis C patients who achieved SVR after DAAs combination therapy.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
85 years-old >
Gender Male and Female
Key inclusion criteria The patients with chronic hepatitis C
Key exclusion criteria 1. Patient who already takes some medicine affecting bone density
2. Patient who is nursing or pregnant
3. Patient with uncontrolled heart failure
4. Patient with uncontrolled hypertension or diabetes
5. Patient with chronic renal failure
6. Patient with decompensated liver cirrhosis
7. Patient with other liver diseases, including autoimmune hepatitis, primary biliary cirrhosis and alcoholic hepatitis
8. Patient with positive result for hepatitis B surface antigen and antibody to human immunodeficiency virus type-1
9. Patient Judged by investigators not to be appropriate for inclusion in this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476-99-1111
Email atsukawa-nms@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chisa Kondo
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476-99-1111
Homepage URL
Email s8042@nms.ac.jp

Sponsor
Institute Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization None
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
2017 Year 06 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is an observational study analyzed the data of consecutive patients with chronic hepatitis C from February, 2017.

Management information
Registered date
2017 Year 06 Month 11 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.