UMIN-CTR Clinical Trial

Public title

Examination of efficacy and safety of administration of vitamin D3 with the PEG-IFN alpha 2a/Ribavirin therapy to hepatitis C patients with osteoporosis.

Acronym

Vitamin D3 with the PEG-IFN alpha 2a/RBV therapy to hepatitis C patients with osteoporosis.

Scientific Title

Examination of efficacy and safety of administration of vitamin D3 with the PEG-IFN alpha 2a/Ribavirin therapy to hepatitis C patients with osteoporosis.

Scientific Title:Acronym

Vitamin D3 with the PEG-IFN alpha 2a/RBV therapy to hepatitis C patients with osteoporosis.

Region

Japan

Condition

hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the efficacy and safety of administration of vitamin D3 with the PEG-IFN alpha 2a/RBV therapy to hepatitis C patients with osteoporosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Virological response: the rate of patients negative for serum HCV-RNA after 24 weeks of the end of therapy (SVR: sustained virological response)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Vitamin D3 (Alfacalcidol) is administered to the patient with osteoporosis in addition to standard treatment of hepatitis C.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patient diagnosed as chronic hepatitis C or compensated liver cirrhosis due to HCV
2.Genotype 1 type with high viral load (HCV-RNA 100KIU or more) in chronic hepatitis C
3.No the treatment history are asked. 4.Osteoporosis or the bone mass decreased patient.
3.Patient who obtains agreement for participation in present study.

Key exclusion criteria

1.Pregnant woman or woman who has possibility of pregnancy or woman while suckling
2.Patient who has previous history of hypersensitivity for element of ribavirin or other nucleosides analog (aciclovir, ganciclovir, and vidarabine, etc.)
3.Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.)
4.Patient with abnormal haemoglobin syndrome (thalassemia and drepanocytic anemia, etc.)
5.The chronic renal failure or a patient who has the renal dysfunction of CCr 50mL/min or less.
6.Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or patient who has the previous history.
7.Patient with serious liver function trouble
8.Patient with autoimmune hepatitis
9.Patient who is administering the sho-sai-ko-to
10.Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis.
11.Patient who has previous history of hypersensitivity for element of PEG-IFN alpha 2a or other interferon therapy.
12.Patient who has previous history of hypersensitivity for biological products such as vaccines.
13.Patient with cirrhosis, liver failure, and liver carcinoma.
14.Patient who is taking vitamin D3, bisphosphonate, SERM, and vitamin K preparation (Make it to the wash out period on one month or more, of six months or more, of one month or more, of one month or more respectively).
15.Additionally, patient judged by doctor that participation in this study is improper.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Yasushi Seo

Organization

Kobe University Hospital

Division name

Gastroenterology

Zip code

Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Yoshihiko Yano

Organization

Kobe University Hospital

Division name

Gastroenterology

Zip code

Address

TEL

Homepage URL

Email

yanoyo@med.kobe-u.ac.jp

Institute

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name

Organization

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

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

Date of disclosure of the study information

2010

Year

12

Month

01

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

Open public recruiting

Date of protocol fixation

2011

Year

07

Month

04

Day

Date of IRB

Anticipated trial start date

2011

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

27

Day

Last modified on

2017

Year

11

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005522