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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025487
Receipt No. R000029331
Scientific Title Post-marketing, prospective and non-randomized trial regarding to daclatasvir and asunaprevir combination therapy for chronic liver disease with genotype 1 hepatitis C virus
Date of disclosure of the study information 2017/01/04
Last modified on 2017/07/05

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Basic information
Public title Post-marketing, prospective and non-randomized trial regarding to daclatasvir and asunaprevir combination therapy for chronic liver disease with genotype 1 hepatitis C virus
Acronym daclatasvir and asunaprevir combination therapy for chronic liver disease
Scientific Title Post-marketing, prospective and non-randomized trial regarding to daclatasvir and asunaprevir combination therapy for chronic liver disease with genotype 1 hepatitis C virus
Scientific Title:Acronym daclatasvir and asunaprevir combination therapy for chronic liver disease
Region
Japan

Condition
Condition Chronic liver disease with hepatitis C virus (chronic hepatitis and compensated cirrhosis)
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Post-marketing efficacy and safety of daclatasvir and asunaprevir combination therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rate of sustained virological response (SVR) 24 weeks after end of treatment (EoT).
Key secondary outcomes Disappeared rate of HCV RNA during the treatment, EoT and SVR12.
Frequency of adverse effects (grade 3 and over)
Fasting glucose, insulin, HOMA-IR before and after treatment

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 Daclatasvir and asunaprevir combination therapy (daclatasuvir 60 mg/day and asunaprevir 200mg/day) for 24 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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patient who was clinically diagnosed with chronic hepatitis or compensated cirrhosis (Child-Pugh grade A). HCV serotype 1(genotype 1b or 1a) and serum HCV RNA are positive. Men and women aged 20 to 85 years with HCV genotype 1. Patient which will fall under either of the below:a)CCr for 24 hours; equal or over 30mL/min. b)eGFR;equal or over 30mL/min/1.73 m2. Patient who can orally take in. Patient who has no history of hepatocellular carcinoma (HCC) or no evidence of recurrence after HCC treatment at least one year. Written informed consent was obtained.
Key exclusion criteria Previously treatment with daclatasvir and asnaprevir or other NS5A replication complex inhibitor. Decompensated cirrhosis (i.e.Child Pugh grade B or C cirrhosis). Untreated variceal hemorrhage, hepatic encephalopathy or uncontrollable ascites. HBs antigen and or human immunodeficiency virus antibody are positive. Current hepatocellular carcinoma diagnosed by US, CT or MRI(=<1 year from enrollment). Severe or uncontrolled disorder (i.e. myocardial infarction, heart failure, arrhythmia, cerebral infarction). Gastrointestinal disorder that could interfere with the absorption of the study drugs. Significant drug allergy (such as anaphylaxis or hepatotoxicitys). Advanced cancer untreated or during treatment. History of organ implantation.Findings of organ failure or unstableorgan functio. Woman in pregnancy or having a possibility that she may be in pregnancy, in nursing. Woman having a possibility of fertility or male whose partner has a possibility of fertility cannot use birth control between first treatment day and 6 months after treatment. Man whose partner is in pregnancy cannot use condom between first treatment day and 6 months after treatment. Abnormality in following laboratory tests: AST>5 times UNV, Total bilirubin>=5 mg/dL, Albumin>3 g/dL, Platelet=<50000/mm^3. Patient taking an incompatible drug. Patient restricted by legal reason. Unsuitable case judged by doctor.
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Takikawa
Organization Iwate medical university
Division name Division of hepatology, department of gastroenterology
Zip code
Address Uchimaru 19-1, Morioka, Iwate, Japan
TEL 081-19-651-5111
Email ytakikaw@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Yoshida
Organization Iwate medical university
Division name Division of hepatology, department of gastroenterology
Zip code
Address Uchimaru 19-1, Morioka, Iwate, Japan
TEL 081-19-651-5111
Homepage URL
Email yoshiday@iwate-med.ac.jp

Sponsor
Institute Division of hepatology, department of gastroenterology, Iwate medical university
Institute
Department

Funding Source
Organization Division of hepatology, department of gastroenterology, Iwate medical 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 岩手医科大学附属病院(岩手県)、秋田厚生医療センター(秋田県)、岩手県立江刺病院(岩手県)、岩手県立大船渡病院(岩手県)、岩手県立軽米病院(岩手県)、岩手県立中部病院(岩手県)、岩手県立二戸病院(岩手県)、三愛病院(岩手県)、能代山本医師会病院(秋田県)、盛岡市立病院(岩手県)、盛岡友愛病院(岩手県)、おおうち消化器科内科クリニック(岩手県)、川上医院(岩手県)、吉田消化器科内科(岩手県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 04 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
2014 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 05 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
2016 Year 12 Month 31 Day
Last modified on
2017 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029331

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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