Clinical pharmacology study of NIK-333

Clinical pharmacology study of NIK-333-Search for drug-response gene and examination of safety in patients who were completely cured of hepatitis C virus-positive hepatocellular carcinoma -

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221715

Enrollment

Registered

2012-02-21

Start date

2012-02-21

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
Gene expression profile Liver and peripheral blood gene expression profiles determined by the microarray method	—

Secondary

Measure	Time frame
Safety Adverse events, physiological tests, laboratory tests (hematology tests, blood biochemistry tests, urinalyses, blood pressure parameters), abdominal imaging diagnosis, endoscopy (esophagus/stomach), bone mineral analysis (DXA method), ECG, echocardiography, pulse wave examination (PWV/ABI), fundus examination	—

Outcome results

None listed

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