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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027851
Receipt No. R000031904
Scientific Title Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)
Date of disclosure of the study information 2017/06/21
Last modified on 2017/06/21

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Basic information
Public title Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)
Acronym Efficacy and safety of Ledipasvir/Sofosbuvir in patient with chronic kidney disease
Scientific Title Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)
Scientific Title:Acronym Efficacy and safety of Ledipasvir/Sofosbuvir in patient with chronic kidney disease
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and safety of Ledipasvir and Sofosbuvir combination therapy for genotype1b-infected chronic hepatitis C patients with chronic kidney disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sustained virological response rate
Key secondary outcomes 1. Change in serum HCV RNA during treatment and follow-up duration
2. Change in hematological and biochemical test during treatment and follow-up duration
3.Change of renal function during a treatment period
4. Frequency of a side effect during a treatment period
5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.

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 Patients were treated with Ledipasvir and Sofosbuvir combination therapy
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
18 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients with chronic hepatitis C who treat with Ledipasvir/Sofosbuvir combination therapy.
Key exclusion criteria 1.History of allergy to Ledipasvir and Sofosbuvir.
2.Decompensated liver cirrhosis
3.pregnant woman or lactating mother
4.Hepatocellular carcinoma, or other malignant tumor.
5.severe depression
6.Judged by investigator not to be appropriate for inclusion in this study
7.Patient with dialysis or patients with severe renal function disorder (eGFR<30ml/min/1.73m2)
8.Receiving contraindicated drugs for
Ledipasvir and Sofosbuvir combined therapy
Target sample size 700

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 Masanori Atsukawwa
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 atsukawa-nms@umin.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 Nippon Medical School Hospital
Nippon Medical School Musashi Kosugi Hospital
The Jikei University Hospital
Otakanomori Hospital
Hakujikai Healthcare foundation
Tokyo Metropolitan Bokutoh Hospital
Tokyo Medical University Ibaraki Medical Center
Shinmatsudo Central General Hospital
Japanese Red Cross Narita Hospital
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 21 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 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

Management information
Registered date
2017 Year 06 Month 21 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031904

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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