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

The beneficial effect of branched-chain amino acids with simeprevir with peginterferon alpha-2b plus ribavirin for chronic hepatitis C - The beneficial effect of branched-chain amino acids with simeprevir triple combination therapy for chronic hepatitis C

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016742
Enrollment
100
Registered
2015-03-09
Start date
2014-01-01
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 simeprevir plus peginterferon/ribavirin therapy with BCAA enriched supplement. Patients were treated by simeprevir plus peginterferon/ribavirin therapy without BCAA enriched s

Sponsors

Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) patients who infected HCV-serotype1 2) age, over 20 years old and under 75 years old 3) male and female 4) patients who don't diagnosed cirrhosis by imaging or blood examination 5) patients who has no HCC by imaging examination

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
Sustained virological response

Secondary

MeasureTime frame
1) Negative conversion rate of HCV-RNA (at 4W, 12W, 24W of therapy) 2) Change in hemoglobin 3) Dose of drug (simeprevir, peginterferon, ribavirin) 4) Improvement of insulin resistance 5) Improvement of loss of zinc 6) Improvement of BTR 7) Occurrence of side effect

Countries

Japan

Contacts

Public ContactIsao Hidaka

Yamaguchi Univercity Graduate School of Medicine Department of Gastroenterology and Hepatology

isao-h@yamaguchi-u.ac.jp0836-22-2241

Outcome results

None listed

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