UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019659 |
|---|---|
| Receipt number | R000022569 |
| Scientific Title | A pilot study to evaluate efficacy and safety of sofosbuvir and daclatasvir for HCV genotype 3 infection in HIV and HCV co-infected hemophiliacs |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2022/11/11 12:51:22 |
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Basic information
Public title
A pilot study to evaluate efficacy and safety of sofosbuvir and daclatasvir for HCV genotype 3 infection in HIV and HCV co-infected hemophiliacs
Acronym
Sofosbuvir and daclatasvir for HCV genotype 3 in HIV co-infected hemophiliacs
Scientific Title
A pilot study to evaluate efficacy and safety of sofosbuvir and daclatasvir for HCV genotype 3 infection in HIV and HCV co-infected hemophiliacs
Scientific Title:Acronym
Sofosbuvir and daclatasvir for HCV genotype 3 in HIV co-infected hemophiliacs
Region
| Japan |
Condition
Condition
HIV infection, AIDS, Chronic hepatitis C infection
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The main objective of this trial is to evaluate the efficacy and safety of a treatment with sofosbuvir and daclatasvir for HCV genotype 3 infection in HIV/HCV co-infected hemophiliacs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is a sustained virologic response at week 12 after the end of therapy.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive sofosbuvir 400mg plus daclatasvir 60mg once daily for 12 weeks.
In patients receiving antiretroviral therapy with protease inhibitor plus booster, dose of daclatasvir is adjusted to 30mg.
In patients receiving antiretroviral therapy with non-nucleic acid reverse transcriptase inhibitor except for rilpivirine, dose of daclatasvir is adjusted to 90mg.
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
Key inclusion criteria
Hemophiliacs infected with HIV and HCV genotype 3
Patients did not complete treatment or treatment failure with IFN
An HCV RNA positive at screening
HIV RNA less than 50 copies per mL for at least 8 weeks prior to screening
CD4 cell count must be more than 200 cells per micro liter for at least 8 weeks prior to screening
Men must agree to follow contraception for the duration of treatment with study drugs and 14 weeks post treatment completion
Patients agree to take study drugs that are not approved to use as a combination even though both drugs are approved for each in HCV treatment
Key exclusion criteria
Decompensated liver disease
Severe renal impairment eGFR less than 30mL per min per 1.73m2
HBsAg seropositive
Presence of active AIDS defining opportunistic infections to treat
Use of prohibited treatments rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, dexamethasone, St. John's wort containing food
Any other medical, psychiatric or social reason wich, in the opinion of the investigator would make the subject inappropriate for the study
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Oka |
Organization
National center for global health and medicine
Division name
AIDS clinical center
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku, Tokyou, Japna
TEL
03-3202-7181
oka@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Uemura |
Organization
National center for global health and medicine
Division name
AIDS clinical center
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku, Tokyou, Japna
TEL
03-3202-7181
Homepage URL
huemura@acc.ncgm.go.jp
Sponsor or person
Institute
National center for global health and medicine
Institute
Department
Personal name
Funding Source
Organization
National center for global health and medicine
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
National center for global health and medicine Ethical Committee
Address
1-21-1, Toyama, Shinjuku, Tokyou, Japna
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
National center for global health and medicine
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
3
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022569
