![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040609 |
Receipt No. | R000046278 |
Scientific Title | Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases |
Date of disclosure of the study information | 2020/06/01 |
Last modified on | 2020/06/01 |
Basic information | ||
Public title | Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases | |
Acronym | Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases | |
Scientific Title | Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases | |
Scientific Title:Acronym | Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases | |
Region |
|
Condition | ||
Condition | Chronic hepatitis C | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | We plan to collect clinical data of patients who are treated with sofosbuvir + velpatasvir + ribavirin at our hospital and clarify the actual condition of the treatment. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The significance of this study is to collect clinical data on treatment and to clarify the association with drug resistance mutations. |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients over 20 years old | |||
Key exclusion criteria | Patients who cannot regularly visit the outpatient department of hepatobiliary-pancreatic medicine.
Patients with hepatocellular carcinoma. Patients with impaired renal function (eGFR 30 ml / min / less than 1.73 m2). Patients who are allergic to this drug. Patients who are taking contraindications for this study drugs. Patients who are judged by the attending physician to possibly impair patient safety. |
|||
Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | School of Medicine and Graduate school of Medicine Osaka City University | ||||||
Division name | Department of Hepatology | ||||||
Zip code | 545-8585 | ||||||
Address | 1-4-3, Asahimachi, Abeno, Osaka 545-8585, JAPAN | ||||||
TEL | 06-6645-3905 | ||||||
atamori@med.osaka-cu.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | School of Medicine and Graduate school of Medicine Osaka City University | ||||||
Division name | Department of Hepatology | ||||||
Zip code | 545-8585 | ||||||
Address | 1-4-3, Asahimachi, Abeno, Osaka 545-8585, JAPAN | ||||||
TEL | 06-6645-3905 | ||||||
Homepage URL | |||||||
atamori@med.osaka-cu.ac.jp |
Sponsor | |
Institute | School of Medicine and Graduate school of Medicine Osaka City University |
Institute | |
Department |
Funding Source | |
Organization | School of Medicine and Graduate school of Medicine Osaka City University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | School of Medicine and Graduate school of Medicine Osaka City University |
Address | 1-4-3, Asahimachi, Abeno, Osaka 545-8585, JAPAN |
Tel | 06-6645-3456 |
ethics@med.osaka-cu.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | To confirm the efficacy and safety of patients who have received this treatment. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046278 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |