UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019011 |
|---|---|
| Receipt number | R000021980 |
| Scientific Title | A Study on Predictors of Treatment Response to Sofosbuvir and Ledipasvir Therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2022/10/06 10:08:57 |
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Basic information
Public title
A Study on Predictors of Treatment Response to Sofosbuvir and Ledipasvir Therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection
Acronym
Predictor of treatment response to SOF LDV therapy
Scientific Title
A Study on Predictors of Treatment Response to Sofosbuvir and Ledipasvir Therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection
Scientific Title:Acronym
Predictor of treatment response to SOF LDV therapy
Region
| Japan |
Condition
Condition
Patients with genotype 1 HCV infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of sofosbuvir plus ledipasvir therapy in patients with a chronic HCV genotype 1 infection, and investigate predictors of treatment response based on the analyses of viral and host factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the predictors obtained at baseline and affecting the sustained virologic response (SVR) rate/occurrence of adverse drug reactions at follow-up Week 12
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study.
(1) Subjects
Patients with a chronic HCV infection and compensated cirrhosis who are being treated as outpatients or inpatients at institutions participating in this study
(2) Inclusion criteria
[1] Patients who are 20 years of age or older at the time of informed consent
[2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation
[3] Patients with a chronic HCV genotype 2 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
Key exclusion criteria
1 Patients with poorly controlled cardiac disease (myocardial infarction, cardiac failure, arrhythmia)
2 Patients with severe hepatic impairment
3 Patients with a history of hypersensitivity to HCV NS5B inhibitors or Ribavirin
4 Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment
5 Patients deemed unsuitable for study entry by their treating physician
6 Patients with renal dysfunction
7 Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code
Address
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL
+81-11-716-1161
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code
Address
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaido
TEL
+81-11-716-1161
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
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
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
JCHO Sapporo Hokushin Hospital
Sapporo City General Hospital
Abashiri-Kosei General Hospital
Obihiro-Kosei General Hospital
JCHO Hokkaido Hospital
National Hospital Organization Hokkaido Medical Center Hokkaido Gastroenterology Hospital
Aiiku Hospital
Sapporo Hokuyu Hospital
Kushiro Rosai Hospital
Hakodate Central General Hospital
Hakodate Medical Association Hospital
NTT EAST Sapporo Hospital
Tomakomai City Hospital
Japanese Red Cross Kitami Hospital
Iwamizawa Municipal General Hospital
Wakkanai City Hospital
Tomakomai Nissho Hospital
Sapporo Century Hospital
Touei hospital
Hakodate City General Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is cohort study
Way for subscription
Patients who visit our hospital between October 2015 and march 2018, and meet inclusion criteria are enrolled.
We will check below
1 Viral factors: HCV NS5A/NS3 inhibitor resistant mutations
2 Peripheral blood tests: WBC, differential WBC, Hb, and Plt
3 Liver function tests AST, ALT and ALP
4 Biochemistry LDH, BUN, total bilirubin, direct bilirubin, ALP, GTP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase
5 Fibrosis markers: hyaluronic acid, type IV collagen etc, and AFP
6 Glucose tolerance tests fasting glucose, insulin, and HbA1c; Lipid metabolism: TC, LDL-C, and TG; Blood coagulation
7 Viral kinetics: serial measurement of viral load
8 Measurement of liver stiffness by liver biopsy FibroScan
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021980
