UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018855 |
|---|---|
| Receipt number | R000021809 |
| Scientific Title | Prevention of hepatocarcinogenesis after combinatoin therapy with daclatasvir and asunaprevir : A pilot study in usefulness of a small amount of Peg-interferon |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2018/06/26 09:17:05 |
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Basic information
Public title
Prevention of hepatocarcinogenesis after combinatoin therapy with daclatasvir and asunaprevir : A pilot study in usefulness of a small amount of Peg-interferon
Acronym
Prevention of hepatocarcinogenesis after combinatoin therapy with daclatasvir and asunaprevir
Scientific Title
Prevention of hepatocarcinogenesis after combinatoin therapy with daclatasvir and asunaprevir : A pilot study in usefulness of a small amount of Peg-interferon
Scientific Title:Acronym
Prevention of hepatocarcinogenesis after combinatoin therapy with daclatasvir and asunaprevir
Region
| Japan |
Condition
Condition
Among genotye 1b HCV infected patients who achieved SVR in combination therapy with daclatasvir and asunaprevir, patients that serum AFP value is greater than or equal to 6.0 ng / mL at post-treatment 24 weeks
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among patients after elimination of HCV, to predict whether a small amount of administration of IFN leads to prevention of hepatocarcinogenesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
level of serum AFP
Key secondary outcomes
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
45 micro gram of Pegylated interferon-alpha2a (Pegasys) is administered 12 times every four 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients who achieved SVR after combination therapy with daclatasvir and asunaprevir, patients that serum AFP value is greater than or equal to 6.0 ng / mL at post-treatment 24 weeks
Key exclusion criteria
patients with HCC
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satochi Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
38 Morohongo, Moroyama-Machi, Iruma-Gun, Saitama
TEL
049-276-1198
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Uchida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
38 Morohongo, Moroyama-Machi, Iruma-Gun, Saitama
TEL
049-276-1198
Homepage URL
y_uchida@saitama-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology & Hepatology,
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology & Hepatology,
Saitama 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
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
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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 30 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021809
