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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000004252 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Chronic hepatitis type C | |
Classification by specialty |
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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 |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 100 |
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Name of lead principal investigator |
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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 |
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Organization | Yamaguchi Univercity Graduate School of Medicine | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | 1-1-1 Minamikogushi, Ube, Yamaguchi | ||||||
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Homepage URL | |||||||
Sponsor | |
Institute | Department of Gastroenterology,
Yamaguchi Univercity Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Gastroenterology,
Yamaguchi Univercity Graduate School of Medicine |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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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 |
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Last follow-up date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005026 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |