UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025487 |
|---|---|
| Receipt number | 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 | 2023/07/07 13:15:56 |
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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 | Yasuhiro |
| Middle name | |
| Last name | Takikawa |
Organization
Iwate medical university
Division name
Division of hepatology, department of gastroenterology
Zip code
020-8505
Address
Uchimaru 19-1, Morioka, Iwate, Japan
TEL
081-19-651-5111
ytakikaw@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Yoshida |
Organization
Iwate medical university
Division name
Division of hepatology, department of gastroenterology
Zip code
020-8505
Address
Uchimaru 19-1, Morioka, Iwate, Japan
TEL
081-19-651-5111
Homepage URL
yoshiday@iwate-med.ac.jp
Sponsor or person
Institute
Iwate medical university
Institute
Department
Personal name
Funding Source
Organization
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
the Iwate Medical University Ethics Committee
Address
Idaidori 2-1-1, Yahaba, Iwate, Japan
Tel
081-19-651-5111
yoshiday@iwate-med.ac.jp
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
No URL exists
Publication of results
Published
Result
URL related to results and publications
https://www.jsgg.org/index.php?page=journal_backnumber
Number of participants that the trial has enrolled
182
Results
The undetectable rate of HCV RNA 24 weeks after the end or stop of treatment was 90.6%. During the treatment, adverse effects were seen in 123 patients. The most frequent adverse effect was elevation of transaminase. There was no difference in rate of sustained viral response or frequency of adverse effect between non-elderly and elderly patients. Conclusions: Efficacy and safety during DCV and ASV combination therapy for elderly patients were similar to non-elderly patients.
Results date posted
| 2023 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 182 patients with chronic hepatits or compensated cirrhosis infected with hepatitis c virus genotype 1 were included. Of 182 participants, 94 were male, and 59 participants were complicated with cirrhosis.
Participant flow
Patients who dicided to undergo the daclatasvir and asunaprevir combination therapy received explanations from a doctor, and was arbitrary to participate in this study.
Adverse events
During the treatment, adverse effects were seen in 123 patients. The most frequent adverse effect was elevation of transaminase.
Outcome measures
Sustaind viral response rate was 90.6% 24 weeks after the treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 06 | Day |
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
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029331
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