Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients

Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients - Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003457

Enrollment

Registered

2010-04-09

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

Chronic hepatitis C

Interventions

Standard therapy is performed for 48 weeks with pegylated IFN alpha-2b+ribavirin. Further, hydroxyurea is administered in combination as follows. Phase I trial: each levels of HU is orally administe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age>=50 to <80years Chronic hepatitis C patients HBs Ag negative HCV RNA>= 5LogIU/mL Neutrophils: >=1,500/uL Platelets: >=80,000/uL Hemoglobin: >=10g/dL BW: >=40kg Patients with Informed consent

Exclusion criteria

Exclusion criteria: 1)Pregnant or lactating Women 2)Patients with uncontrolled heart disease 3)Patients with uncontorolled DM or HT 4)Patients with inadequate haematological status 5) Patients with exclusion criteria for PEG/RBV therapy 6) Patient with decision of exclusion

Design outcomes

Primary

Measure	Time frame
PhaseI:The safety PhseII:Antiviral effect	—

Secondary

Measure	Time frame
PhaseI:Antiviral effect PhaseII: The safety, ALT change	—

Countries

Japan

Contacts

Public ContactAkito Nozaki

Yokohama City University Medical Center Gastroenterological Center

Outcome results

None listed

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