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The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients

The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients - The beneficial effect of branched-chain amino acids with combined peginterferon plus ribavirin for chronic hepatitis C patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004252
Enrollment
100
Registered
2010-09-24
Start date
2010-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis type C

Interventions

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

Sponsors

Department of Gastroenterology, Yamaguchi Univercity Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Rate of nagative HCV RNA at 24 weeks after the initiation of treatment (The SVR rate)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactIsao Hidaka

Yamaguchi Univercity Graduate School of Medicine Department of Gastroenterology and Hepatology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026