UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038604 |
|---|---|
| Receipt number | R000043998 |
| Scientific Title | Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2023/02/22 16:35:19 |
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Basic information
Public title
Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection
Acronym
Harvoni in Genotype 2 HCV patients
Scientific Title
Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection
Scientific Title:Acronym
Harvoni in Genotype 2 HCV patients
Region
| Japan |
Condition
Condition
Patients With Hepatitis C Virus Genotype 2 Infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
fficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and efficacy of ledipasvir-sofosbuvir for 12 weeks treatment with Japanese GT2 patients
Key secondary outcomes
Completion rate for treatment completion (without discontinuation of safety reason).
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
More than 20 years old and had chronic infection with HCV genotype 2.
With or without Child-Pugh A compensated cirrhosis.
Body weight more than 40 kg.
Written informed consent
Key exclusion criteria
Prior exposure to a direct-acting antiviral agent targeting HCV NS5A or NS5B
Decompensated cirrhosis
Creatinine clearance (Cockcroft-Gault) less than 30 mL/min
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Toyoda |
Organization
Ogaki Municipal Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
503-8502
Address
4-86 Minaminokawa, Ogaki, Gifu, Japan
TEL
+81-584-81-3341
tkumada@he.mirai.ne.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kumada |
Organization
Gifu Kyoritsu University
Division name
Department of Nursing, Faculty of Nursing
Zip code
503-8550
Address
5-50, Kitagata-cho, Ogaki city, Gifu prefecture
TEL
+81-584-77-3512
Homepage URL
takashi.kumada@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences, Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Internal Medicine, Japanese Red Cross Society Himeji Hospital
Department of Hepatology, Kagawa Prefectural Central Hospital
Center for Gastroenterology, Teine Keijinkai Hospital
Gastroenterology Center, Ehime Prefectural Central Hospital
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital
Department of Gastroenterology, Asahi General Hospital
Department of Hepatology, Saiseikai Niigata Daini Hospital
Department of Gastroenterology, Okayama City Hospital
Department of Gastroenterology, Tokushima Prefectural Central Hospital
Division of Gastroenterology, Department of Internal Medicine, Kikkoman General Hospital
Department of Gastroenterology, Okayama Saiseikai General Hospital
Department of Gastroenterology and Hepatology, Kagoshima City Hospital
Division ofGastroenterology and Hepatology,NipponMedical School
Chihaya Hospital
Department of Gastroenterology, Takarazuka City Hospital
Kobe Asahi Hospital
Takamatsu Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ogaki Municipal Hospital
Address
-86 Minaminokawa, Ogaki, Gifu, Japan, 503-8502
Tel
+81-584-81-3341
clinical-trial@omh.ogaki.gifu.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33141401/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33141401/
Number of participants that the trial has enrolled
126
Results
The overall SVR rates of the ITT and mITT populations were 87.3% (95% confidence interval [CI] 80.2-92.6) (110/126) and 97.3% (95% CI 92.4-99.4) (110/113), respectively. In the mITT population, the percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 92.9% (95% CI 86.5-96.9) (105/113), 99.1% (95% CI 95.2-100.0) (112/113), and 100.0% (95% CI 97.4-100.0) (113/113), respectively.
Results date posted
| 2023 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Results: The overall SVR rates of the ITT and mITT populations were 87.3% (95% confidence interval [CI] 80.2-92.6) (110/126) and 97.3% (95% CI 92.4-99.4) (110/113), respectively. In the mITT population, the percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 92.9% (95% CI 86.5-96.9) (105/113), 99.1% (95% CI 95.2-100.0) (112/113), and 100.0% (95% CI 97.4-100.0) (113/113), respectively. Subgroup analyses of the mITT population showed no significant differences in SVR rates according to age, sex, HCV genotype (subtype), history of interferon-based therapy, baseline FIB-4 index, or baseline estimated glomerular filtration rate. In all subpopulations, the SVR rates were > 90%. There were no severe adverse events associated with the treatment.
Participant flow
A total of 126 patients with chronic hepatitis C due to HCV genotype 2 infection who were treated with the LDV/SOF regimen were enrolled. The sustained virological response (SVR) rate and safety were analyzed. SVR was assessed in the intention-to-treat (ITT) population as well as in the modified intention-to-treat (mITT) population, which excluded patients with non-virological failure, including those who dropped out before the SVR assessment.
Adverse events
None
Outcome measures
The LDV/SOF regimen showed high virological efficacy and acceptable safety in patients with HCV genotype 2 infection.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Ehime Prefectural Central Hospital
Kagawa Prefectural Central Hospital
Management information
Registered date
| 2019 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043998
