Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.

Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load. - Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003410

Enrollment

Registered

2010-04-01

Start date

2010-04-01

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

patients with HCV genotype 1 and high viral load

Interventions

Interferon-beta Peginterferon-alpha Ribavirin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HCV-RNA-positive patients. Patinets with genotype 1b and high viral load (equal to or more than 5.0 LogIU/mL). Leukocyte count (equal to or more than 1500/mm3). Neutrophil count (equal to or more than 750/mm3). Blood platelet count (equal to or more than 50,000/mm3). Hemoglobin concentration (equal to or more than 10g/dL).

Exclusion criteria

Exclusion criteria: Patients with autoimmune hepatitis. Pregnant woman, woman of child-bearing potential, or breast-feeding woman. Patients and thier partners who cannot use birth control durinf therapy and for 6 months after end of administration. Patients with hypersensitivity to ribavirin, or other nucleoside analogs. Patients with uncontrollable heart failure. Patients with hemoglobinopathy. Patinets with chronic renal failure and compromised renal function (equal to or less than 50mL/min of creatinine clearance. Patients with severe depression or psychiatric disease including suicide attempt or with history of suicide attempt. Patients with severe liver dysfunction. Patients with hypersensitivity to biological drug such as vaccine. Patients with hypersensitivity to interferon and bovine-derived material. Patients with interstitial pneumonia. Patients with a history of drug sensitivity or with allergic tendency. Patients administrated with Syousaikotou. Patients with being disqualified by the doctor. Patients who received peginterferon plus ribavirin therapy.

Design outcomes

Primary

Measure	Time frame
The Sustained virological response (SVR) rate	—

Secondary

Measure	Time frame
The rate of loss of serum HCV-RNA levels and viral dynamics during therapy The incidence ratio of adverse effect	—

Countries

Japan

Contacts

Public ContactKen Sato

Gunma University Graduate School of Medicine Department of Medicine and Molecular Science

satoken@gunma-u.ac.jp027-220-8127

Outcome results

None listed

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