UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001034
Receipt number R000001205
Scientific Title A prospective cohort study of peginterferon alpha-2a plus ribavirin treatment in patients with chronic hepatitis C.
Date of disclosure of the study information 2008/02/29
Last modified on 2011/08/22 10:06:39

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Basic information

Public title

A prospective cohort study of peginterferon alpha-2a plus ribavirin treatment in patients with chronic hepatitis C.

Acronym

A prospective study of peginterferon alpha-2a plus ribavirin for chronic hepatitis C.

Scientific Title

A prospective cohort study of peginterferon alpha-2a plus ribavirin treatment in patients with chronic hepatitis C.

Scientific Title:Acronym

A prospective study of peginterferon alpha-2a plus ribavirin for chronic hepatitis C.

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate prospectively the efficacy and safety of peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Negative results of qualitative HCV RNA test at weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy.

Key secondary outcomes

1. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy.
2. Adverse event and laboratory abnormality (changes in neutrophil count, platelet count, and hemoglobin concentration).
3. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy.
4. HCV Core and NS5A ISDR amino acid replacement and virological response.


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

Combination therapy of peginterferon alpha-2a plus ribavirin.

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

Patients with HCV serogroup 1 (Genotype 1a or 1b) and high viral load (HCV RNA >= 100 KIU/mL) or non-responders or relapsers to the previous standard interferon monotherapy.

Key exclusion criteria

1. Pregnant or under breast feeding.
2. Allergic to ribavirin or other nucleoside preparations.
3. Uncontrolled cardiovascular diseases.
4. Abnormal hemoglobinemia.
5. Chronic renal failure or creatinine clearance value less than 50 mL/min.
6. Depression or psychiatric disorders.
7. Sever or decompensated liver disease.
8. Autoimmune liver diseases.
9. White blood cell count <3,000/microL, neutrophil count <1,500/microL, platelet count <90,000/microL, or hemoglobin concentration <12 g/dL.
10. Allergic to pegylated interferon alpha-2a or other interferon preparations.
11. Allergic to vaccine or biological preparations.
12. Concomitant herbal medication such as Sho-saiko-to.
13. Other conditions considered inappropriate by attending physician.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Iwasaki

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan

TEL

086-235-7219

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshiaki Iwasaki

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan

TEL

086-235-7219

Homepage URL


Email



Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

2008 Year 02 Month 29 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2007 Year 09 Month 26 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 01 Day

Last follow-up date

2011 Year 06 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

2008 Year 02 Month 14 Day

Last modified on

2011 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001205


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name