Hepatitis C with hemophilia patient
Conditions
Interventions
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.
Sponsors
Tokyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness evaluation: Virological response is defined as undetectable HCV-RNA at 12 weeks after therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation: Confirmation of adverse events (AEs) and concomitant medications during treatment | — |
Countries
Japan
Contacts
Public ContactTakeshi Hagiwara
Tokyo Medical University Department of Laboratory Medicine
Outcome results
None listed