A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients

A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients - A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003131

Enrollment

Registered

2010-02-05

Start date

2009-01-01

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 C

Interventions

Phase I: dosage of each levels Level1:Hydrea capsule 1500mg/day Level2:Hydrea capsule 1000mg/day Level3:Hydrea capsule 500mg/day PhaseII: RD decided in Phase I trial

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic hepatitis C patients HBs Ag negative HCV RNA> 5LogIU/ML Neutrophils: >1,500/uL Platelets: >70,000/uL Hemoglobin: >10g/dL BW: >40kg Patients with Informed consent

Exclusion criteria

Exclusion criteria: Pregnant Women Patients with Severe heart disease Patients with Severe DM, HT Patients without selectable factors

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

akino@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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