Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

NCT ID: NCT01640808

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 616 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-11-30

Brief Summary

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.

Conditions

Hepatic Neoplasm Malignant Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

NIK-333(peretinoin)

Group Type: EXPERIMENTAL

NIK-333(peretinoin)

Intervention Type: DRUG

600mg (8 x 75mg capsules) orally, twice a day

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (8 x Placebo capsules) orally, twice a day

Interventions

NIK-333(peretinoin)

600mg (8 x 75mg capsules) orally, twice a day

Intervention Type: DRUG

Placebo

Placebo (8 x Placebo capsules) orally, twice a day

Intervention Type: DRUG

Eligibility 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. 4 Patients who want to receive antiviral therapy such as concomitant therapy with intaferon 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Company, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Kashiwa, Chiba, Japan

Matsuyama, Ehime, Japan

Iizuka, Fukuoka, Japan

Kurume, Fukuoka, Japan

Ōgaki, Gifu, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Himeji, Hyōgo, Japan

Kobe, Hyōgo, Japan

Nishinomiya, Hyōgo, Japan

Kanazawa, Ishikawa-ken, Japan

Kawasaki, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Nankoku, Kochi, Japan

Kurashiki, Okayama-ken, Japan

Ikeda, Osaka, Japan

Moriguchi, Osaka, Japan

Sakai, Osaka, Japan

Sayama, Osaka, Japan

Suita, Osaka, Japan

Iruma, Saitama, Japan

Sunto-gun, Shizuoka, Japan

Shimotsuke, Tochigi, Japan

Bunkyo-ku,, Tokyo, Japan

Bunkyo-ku, Tokyo, Japan

Bunkyo-ku, Tokyo, Japan

Chiyoda-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Minato-ku, Tokyo, Japan

Musashino, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shibuya-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Shimonoseki, Yamaguchi, Japan

Ube, Yamaguchi, Japan

Kofu, Yamanashi, Japan

Chiba, , Japan

Fukuoka, , Japan

Fukuoka, , Japan

Gifu, , Japan

Gifu, , Japan

Hiroshima, , Japan

Hiroshima, , Japan

Kagoshima, , Japan

Kumamoto, , Japan

Nagasaki, , Japan

Niigata, , Japan

Okayama, , Japan

Osaka, , Japan

Osaka, , Japan

Osaka, , Japan

Osaka, , Japan

Osaka, , Japan

Ōita, , Japan

Saga, , Japan

Saga, , Japan

Tokushima, , Japan

Tokushima, , Japan

Wakayama, , Japan

Countries

Japan

Other Identifiers

NIK-333-05

Identifier Type: -

Identifier Source: org_study_id