UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004252 |
|---|---|
| Receipt number | R000005026 |
| Scientific Title | The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients |
| Date of disclosure of the study information | 2010/09/24 |
| Last modified on | 2012/10/12 13:33:56 |
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Basic information
Public title
The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients
Acronym
The beneficial effect of branched-chain amino acids with combined peginterferon plus ribavirin for chronic hepatitis C patients
Scientific Title
The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients
Scientific Title:Acronym
The beneficial effect of branched-chain amino acids with combined peginterferon plus ribavirin for chronic hepatitis C patients
Region
| Japan |
Condition
Condition
Chronic hepatitis type C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the efficancy of branched-chain amino acid (BCAA) with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients by prospective randomized trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of nagative HCV RNA at 24 weeks after the initiation of treatment (The SVR rate)
Key secondary outcomes
1) Rate of negative HCV RNA (at 4 weeks, 12 weeks of combination therapy and end of the initiation therapy)
2) Change in hemoglobin
3) Dose of drug (peginterferon dose, ribavirin dose)
4) Change in insulin resistance
5) Occurrence of side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients were treated by combination therapy of peg-interferon alpha 2b and ribavirin with or without BCAA.
[group 1]therapy with 2 pack of the BCAA enriched supplement (aminofeel, TERUMO)
[group 2]therapy without BCAA enriched supplement
Interventions/Control_2
Patients were treated by combination therapy of peg-interferon alpha 2b and ribavirin for 48-72 week in HCV-serotype 1, serum HCV RNA level of over 5.0 log IU/ml, for 24 week in HCV-serotype 1, serum HCV RNA level of under 5.0 log IU/ml and serotype 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients whose HCV-serotype 1 or 2
2) age, over 20 years old and under 75 years old
3) male and female
4) Patients who don't diagnosed cirrhosis by imaging findings or blood exsamination.
5) Patients who has no HCC by imaging findings.
Key exclusion criteria
1) Patient whose serum HCV RNA level under 5.0 log IU/ml and who taken initial therapy.
2) Patients with sensitivities for peg-interferon alpha 2b or other interferons.
3) Patients with sensitivities for vaccine.
4) Patients with sensitivities for ribavirin or other nucleic acid analogs.
5) a pregnant woman, or woman who may pregnant and who are nursing.
6) PAtients who had bad controled heart disease.
7) Patients who had hemoglobinemia.
8) Patients who had Chronic renal failure or whose creatinine clearance under 50ml/min.
9) Patients who had depression.
10) Patients who had severe liver disfunction or bile duct obstruction.
11) Patients who had cerebral hemorrhage or cerebral infarction.
12) PAtients who medicated by shousaikoto.
13) Patients who had autoimmune hepatitis.
14) Patients who had chronic hepatitis type B, alcoholic liver injury.
15) Patients who were disqualified by doctor in attendance.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Hidaka |
Organization
Yamaguchi Univercity Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Hidaka |
Organization
Yamaguchi Univercity Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology,
Yamaguchi Univercity Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology,
Yamaguchi Univercity Graduate School of Medicine
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
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
山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 24 | 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
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 22 | Day |
Last modified on
| 2012 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005026
