UMIN-CTR Clinical Trial

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

Hepatitis C with hemophilia patient

Classification by specialty

Hepato-biliary-pancreatic medicine

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

fukutake@tokyo-med.ac.jp

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

Email

thagi@tokyo-med.ac.jp

Institute

Tokyo Medical University

Institute

Department

Personal name

Organization

Health Labour Sciences Research Grant

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2016

Year

03

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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