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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038587
Receipt No. 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 2019/11/14

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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
Email 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
Email leaf0710@nms.ac.jp

Sponsor
Institute Nippon Medical School, Division of Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department

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
Email 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 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 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
2019 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043972

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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