Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Kowa Company, Ltd.
Sponsor:
Information provided by (Responsible Party):
Kowa Company, Ltd.
ClinicalTrials.gov Identifier:
NCT01640808
First received: July 10, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study.


Condition Intervention Phase
Hepatic Neoplasm Malignant Recurrent
Drug: NIK-333(peretinoin)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: NIK-333 (Peretinoin) Phase ⅢStudy Investigation of the Efficacy and Safety to Suppress Recurrence of Hepatitis C Virus (HCV)-Positive Hepatocellular Carcinoma(HCC), Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group Study

Resource links provided by NLM:


Further study details as provided by Kowa Company, Ltd.:

Primary Outcome Measures:
  • Recurrence-free survival

Estimated Enrollment: 600
Study Start Date: April 2012
Arms Assigned Interventions
Experimental: NIK-333(peretinoin) Drug: NIK-333(peretinoin)
600mg (8 x 75mg tablets) orally, twice a day, continuously until recurrence of HCC, the patient's death, or termination or discontinuation of the entire study.
Placebo Comparator: Placebo Drug: Placebo
600mg (8 x 75mg tablets) orally, twice a day, continuously until recurrence of HCC, the patient's death, or termination or discontinuation of the entire study.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with HCV-positive HCC who meet the following conditions before radical treatment

    • Patients diagnosed as having typical HCC on dynamic CT,CTA/CTAP, or dynamic MRI (nodule visualized as a high signal intensity area in the arterial phase and as a relatively low signal intensity area in the portal and equilibrium phases) performed within 8 weeks (56 days) before treatment start prior to radical therapy
    • Patients with the first primary HCC or the first recurrence of primary HCC
  2. Patients who received the radical therapies. The treatment duration (from the start to the end of the treatment) should be within 4 weeks (28 days) for each of the radical therapies.
  3. Patients showing a complete cure, as confirmed by the dynamic CT images taken from 8 weeks (56 days) to 12 weeks (84 days) after the end of the treatment show a non-stained low-concentration area overlapping the tumor image observed before complete cure.
  4. Patients who are able to begin treatment with the study drug within 8 weeks (56 days) after dynamic CT to confirm complete cure
  5. Patients confirmed of satisfying the following conditions based on the screening performed at subject registration

    • Positive for serum hepatitis C virus nucleic acid (HCV-RNA)
    • Grade A on Child-Pugh classification
    • Platelet count of 50 000/µL or higher
  6. Patients with ECOG Performance Status score of 0 to 1
  7. Patients of the age of 20 years or older at the time of informed consent

Exclusion Criteria:

  1. Patients positive for HBs antigen
  2. Patients showing vascular invasion of HCC on imaging diagnosis
  3. Patients who have also undergone transcatheter arterial embolization therapy (TAE/TACE), transarterial infusion therapy (TAI), and chemolipiodolization in combination with the radical therapy
  4. Patients who want to receive antiviral therapy such as interferon during the study period
  5. Patients who have received other study drugs, anticancer drugs, or interferons after radical therapy
  6. Patients who have hypertension as a complication, and whose blood pressure cannot be controlled by drug therapy (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, as determined at subject registration)
  7. Patients who have a history of allergy to CT contrast media, and whose participation in this study is judged to be inappropriate by the investigator or the subinvestigator
  8. Patients with a history of total gastrectomy
  9. Patients with a history of cardiac arrest
  10. Patients with any of the following laboratory values or complications

    • Creatinine>= 1.5mg/dL
    • Albumin urine >= 1000mg/g Creatinine
    • Cardiac disorder corresponding to CTC-AE grade 3 in severity
    • HbA1c >= 7.4 under treatment with insulin
    • Autoimmune disease or asthma being treated with oral steroid
  11. Patients confirmed of having another malignant neoplasm or who had undergone a radical therapy of HCC within the past 5 years to treat another malignant neoplasm (however, this does not apply to endoscopic resection and resection of intraepithelial carcinoma)
  12. Patients who are pregnant, who have a possibility of being pregnant or who have a desire to become pregnant during the study period
  13. Lactating women
  14. Patients who have a history of allergy to retinoid-related substances (vitamin A, etc.) in the past
  15. Patients who participated in another clinical study within past 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640808

Contacts
Contact: Kazuhide Shimada ctrdinfo@kowa.co.jp

  Show 65 Study Locations
Sponsors and Collaborators
Kowa Company, Ltd.
  More Information

No publications provided

Responsible Party: Kowa Company, Ltd.
ClinicalTrials.gov Identifier: NCT01640808     History of Changes
Other Study ID Numbers: NIK-333-05
Study First Received: July 10, 2012
Last Updated: September 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Recurrence
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 19, 2014