UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021544 |
|---|---|
| Receipt number | R000024828 |
| Scientific Title | Evaluation of the effectiveness and safety of Sofosbuvir plus Daclatasvir in the treatment for HCV or HIV/HCV with hemophilia |
| Date of disclosure of the study information | 2016/03/19 |
| Last modified on | 2016/03/19 07:04:07 |
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Basic information
Public title
Evaluation of the effectiveness and safety of Sofosbuvir plus Daclatasvir in the treatment for HCV or HIV/HCV with hemophilia
Acronym
SOF+DCV for HCV with hemophilia
Scientific Title
Evaluation of the effectiveness and safety of Sofosbuvir plus Daclatasvir in the treatment for HCV or HIV/HCV with hemophilia
Scientific Title:Acronym
SOF+DCV for HCV with hemophilia
Region
| Japan |
Condition
Condition
Hepatitis C with hemophilia patient
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is evaluation of the effectiveness and safety of the combination therapy with sofosbuvir plus daclatasvir for HCV with hemophilia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effectiveness evaluation:
Virological response is defined as undetectable HCV-RNA at 12 weeks after therapy.
Key secondary outcomes
Safety evaluation:
Confirmation of adverse events (AEs) and concomitant medications during treatment
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The combination therapy for HCV with sofosbuvir(400mg/day) and daclatasvir(60mg/day) for 12 weeks; For the patients with hemophilia (or related bleeding disorders) infected with two or more HCV genptype(GT), or with GT3, excluding single infection of GT1a, GT1b, GT2a or GT2b.
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 and Female
Key inclusion criteria
Have HCV or HCV/HIV with Hemophilia or other bleeding disorders.
Have had HCV-virological failure from previous IFN therapy or un-adjustment for IFN therapy.
HCV-RNA positive.
In HIV co-infection, HIV viral load < 50 copies/mL and CD4+ lymphocyte > 100/microL during prior 8 weeks.
Able to prevent conception during this treatment (during 12 weeks and after 26 weeks).
20 years old or more of age
Given written informed consent
Key exclusion criteria
HCV-genotype is only GT1 or GT2.
Subjects with un-compensate cirrhosis
Serious renal dysfunction (eGFR<30ml/min/1.73m2)
Positive of HBs antigen
QTcF 500>msec or second/thrid degree of AV-block in ECG
Have active oppotunistic infection required treatment.
The following concomitant medications are not permitted :
Rifampicin, Rifabutin, Phenytoin, Carbamazepine, Phenobarbital, Dexamethasone (given whole body), St. John's wort.
In the opinion of the Investigator makes the subject unsuitable for enrollment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Fukutake |
Organization
Tokyo Medical University
Division name
Department of Laboratory Medicine
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023 Japan
TEL
03-3342-6111
fukutake@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Hagiwara |
Organization
Tokyo Medical University
Division name
Department of Laboratory Medicine
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023 Japan
TEL
03-3342-6111
Homepage URL
thagi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
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
東京医科大学病院（東京都）（Tokyo Medical University Hoapital）、広島大学病院 （広島県）(Hiroshima University Hoapital)、大阪医療センター （大阪府）(National Hospital Organization Osaka National Hospital)、北海道大学病院（北海道） (Hokkaido University Hoapital)、荻窪病院 (Ogikubo Hospital)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 22 | 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
| 2016 | Year | 03 | Month | 19 | Day |
Last modified on
| 2016 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024828
