UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038587 |
|---|---|
| Receipt number | R000043972 |
| Scientific Title | Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis |
| Date of disclosure of the study information | 2019/11/15 |
| Last modified on | 2024/01/09 13:54:00 |
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Basic information
Public title
Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis
Acronym
Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis
Scientific Title
Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis
Scientific Title:Acronym
Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis
Region
| Japan |
Condition
Condition
type C decompensated cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of Sofosbuvir / Velpatasvir combination therapy in patients with type C decompensated cirrhosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
SVR12 rate
(Percent of patients with negative HCV RNA 12 weeks after the end of treatment)
Key secondary outcomes
(1) Patient background: age, sex, height, weight, complications, medical history
(2) Subjective symptoms
(3) Presence or absence of liver-related complications: hepatic edema, hepatic encephalopathy, esophageal / gastric varices
(4) Clinical laboratory items
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Cases of introducing Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis
(2)Age: 18 years old or older
(3)Gender: No matter what
(4)Hospitalization / outpatient: no question
Key exclusion criteria
(1)Patients with a history of hypersensitivity to the ingredients of this drug
(2)Patients with severe renal dysfunction (eGFR <30 mL / min / 1.73m2) or renal failure requiring dialysis
(3)Patients taking the following drugs
Foods containing carbamazepine, phenytoin, phenobarbital, rifampicin, hypericum (St. John's wort)
(4)Patient who is pregnant or breastfeeding
(5)Patients with hepatocellular carcinoma and other cancers
(6)patients who are judged to be inappropriate for participation in the study by the study doctor
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Atsukawa |
Organization
Nippon Medical School
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
113-8602
Address
1-1-5, sendagi, bunkyo-ku, Tokyo
TEL
0338222131
gachi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hayama |
| Middle name | |
| Last name | Korenobu |
Organization
Nippon Medical School
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
113-8602
Address
1-1-5, sendagi, bunkyo-ku, Tokyo
TEL
0338222131
Homepage URL
leaf0710@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School, Division of Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital Ethics Committee Secretariat
Address
1-1-5, sendagi, bunkyo-ku, Tokyo
Tel
0338222131
nms_fuzokurinri@nms.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
日本医科大学付属病院、日本医科大学千葉北総病院、日本医科大学武蔵小杉病院、大垣市民病院、九州医療センター、香川県立中央病院、聖マリアンナ医科大学、おおたかの森病院、新松戸中央総合病院、東京慈恵会医科大学、東京慈恵会医科大学附属病院、東京慈恵会医科大学附属柏病院、キッコーマン総合病院、東京医科大学茨城医療センター、名古屋市立大学病院、東京都立墨東病院、高松赤十字病院、北里大学、大阪医科大学、博慈会記念病院、愛媛県立中央病院、横浜市立大学附属市民総合医療センター、常磐病院、岡山済生会総合病院、増子記念病院、順天堂練馬病院、藤田医科大学ばんたね病院、石巻赤十字病院、済生会吹田病院、済生会新潟第二病院、手稲渓仁会病院、三豊病院、屋島総合病院、順天堂静岡病院、博慈会記念病院、浜松医科大学、三重大学、山口大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32897520/
Number of participants that the trial has enrolled
Results
Twelve weeks of sofosbuvir/velpatasvir in real-world clinical practice yielded high SVR rates and acceptable safety profiles in decompensated cirrhotic patients with genotypes 1 and 2. Achievement of SVR not only restored the liver functional reserve but also reduced or spared the administration of drugs for related complications.
Results date posted
| 2021 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 08 | Day |
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
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For patients with decompensated cirrhosis type C who orally administer 1 tablet Epclusa combination tablet (Sofosbuvir 400mg / Velpatasvir 100mg) once a day for 12 weeks, every 2 weeks from the end of administration to 12 days after the end of administration Observe after 24 and 24 weeks to assess efficacy and safety.
Management information
Registered date
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043972
