NIK-333 phase2/3study

NIK-333 phase2/3study Investigation of the efficacy to supress recurrence of hepatitis C virus (HCV)-positive hepatocellular carcinoma(HCC)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220246

Enrollment

360

Registered

2006-05-23

Start date

2006-05-23

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

HCV-positive HCC patients after curative treatment

Interventions

investigational material(s) Generic name etc : NIK-333 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who signed written informed consent. Patients who underwent a local therapy or surgical resection after diagnosis of HCV-positive HCC and who subsequently were confirmed by CT of showing a complete cure of HCC. Patients confirmed of satisfying the following conditions based on the screening performed at subject registration. 1) Presence of HCV-RNA in serum 2) Grade A or B on Child-Pugh classification

Exclusion criteria

Exclusion criteria: Patients positive for hepatitis B surface (HBs) antigen

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival Time to recurrence of HCC or death, regardless of cause	—

Secondary

Measure	Time frame
Disease-free survival Time to recurrence of HCC, death, regardless of cause, or occurrence of secondary cancer (malignant tumors other than HCC)	—

Outcome results

None listed

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