UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006285
Receipt number R000007439
Scientific Title The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis
Date of disclosure of the study information 2016/12/31
Last modified on 2014/11/06 09:29:51

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Basic information

Public title

The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis

Acronym

CHALLENGE A plus trial

Scientific Title

The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for chronic hepatitis C patients with osteoporosis

Scientific Title:Acronym

CHALLENGE A plus trial

Region

Japan


Condition

Condition

Chronic hepatitis C with osteoporosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of efficacy and safety of administration of Eldecalcitol with the Peginterferon alpha 2a/Ribavirin therapy to chronic hepatitis C patients with osteoporosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained Virological Response ( SVR )

Key secondary outcomes

ALT normalization
Safety


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

Peginterferon alpha 2a
Ribavirin
Eldecalcitol

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

The following chronic hepatitis C patients with Genotype 1 and high viral lord were eligible to enter the trial
Osteoporosis
HCV-RNA>=5.0 LogIU/mL
WBC counts>=3,000/microL
Neutrophil counts>=1,500/microL
Hemoglobin concentration>=12g/dL
Platelet counts>=90,000/microL
the presense of liver biopsy is not asked
the presense of the IFN treatment history is not asked
patients who provided written informed consent to participate the study prior to enrollment

Key exclusion criteria

The following patients were excluded
women of childbearing potential and pregnancy, lactating women
allergic to ribavirin or other nucleoside analoges
an uncontrollable heart trouble( myocardial infarction, heart failure, or arrhythmia)
hemoglobibopathy ( thalassemia, sickle cell disease)
severe renal disease or Ccr<50mL/min
severe depression or psychosomatic disorders
severe liver disease
autoimmune hepatitis or HBV
drug allegy against interferon
allergic to vaccine or biological preperations
concomitant herbal medication of Sho-saiko-to
history of interstitial pneumonia
patients who take active vitamin D3 other than Eldecalcitol
other conditions considerd
inappropriate by attending physician

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiro Tamori

Organization

Osaka City University, Graduate School of Medicine

Division name

Department of Hepatology

Zip code


Address

1-4-3, Asahimachi, Abeno-ku, Osaka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka City University, Graduate School of Medicine

Division name

Department of Hepatology

Zip code


Address


TEL

06-6645-3811

Homepage URL


Email



Sponsor or person

Institute

Department of Hepatology, Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Osaka City University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 31 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

Enrolled patients were few. Now, new anti-HCV drugs were available for patients with chronic hepatitis C. We decide the discontinuation of the present study.

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

Terminated

Date of protocol fixation

2011 Year 06 Month 09 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2016 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 05 Day

Last modified on

2014 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007439


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name