Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01640808
Recruitment Status : Unknown
Verified February 2015 by Kowa Company, Ltd..
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2012
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
Kowa Company, Ltd.

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: Date of randomization to the date of recurrence of HCC (followed every 12 weeks) .or death (whichever occurs first).Participants will be followed, an expected average of 2 years. ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: Date of randomization to the date of recurrence of HCC (followed every 12 weeks).or death or secondary cancer (malignant tumors other than HCC)(whichever occurs first).Participants will be followed, an expected average of 2 years. ]
  2. Time to recurrence [ Time Frame: Date of randomization to the date of recurrence of HCC(followed every 12 weeks).Participants will be followed, an expected average of 2 years. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01640808

  Hide Study Locations
Nagoya, Aichi, Japan, 466-0065
Nagoya, Aichi, Japan, 467-0001
Kashiwa, Chiba, Japan, 277-8577
Matsuyama, Ehime, Japan, 790-0826
Iizuka, Fukuoka, Japan, 820-0018
Kurume, Fukuoka, Japan, 830-0011
Ogaki, Gifu, Japan, 503-0864
Sapporo, Hokkaido, Japan, 006-8555
Sapporo, Hokkaido, Japan, 060-0033
Sapporo, Hokkaido, Japan, 060-8648
Himeji, Hyogo, Japan, 670-0063
Kobe, Hyogo, Japan, 650-0047
Nishinomiya, Hyogo, Japan, 663-8501
Kanazawa, Ishikawa, Japan, 920-8641
Kawasaki, Kanagawa, Japan, 213-8587
Sagamihara, Kanagawa, Japan, 228-8520
Sagamihara, Kanagawa, Japan, 252-0375
Yokohama, Kanagawa, Japan, 232-0024
Yokohama, Kanagawa, Japan, 241-0815
Nankoku, Kochi, Japan, 783-8505
Kurashiki, Okayama, Japan, 701-0192
Ikdeda, Osaka, Japan, 563-8510
Moriguchi, Osaka, Japan, 570-8507
Osakasayama, Osaka, Japan, 589-8511
Sakai, Osaka, Japan, 591-8025
Suita, Osaka, Japan, 565-0871
Iruma, Saitama, Japan, 350-0495
Sunto-gun, Shizuoka, Japan, 411-8777
Shimotsuke, Tochigi, Japan, 329-0498
Musashino, Tokyo,, Japan, 180-8610
Bunkyo-ku,, Tokyo, Japan, 113-8519
Bunkyo-ku, Tokyo, Japan, 113-0021
Bunkyo-ku, Tokyo, Japan, 113-8655
Chiyoda-ku, Tokyo, Japan, 101-8643
Chuo-ku, Tokyo, Japan, 104-0045
Minato-ku, Tokyo, Japan, 105-8470
Ota-ku, Tokyo, Japan, 143-8541
Setagaya-ku, Tokyo, Japan, 158-8531
Shibuya-ku, Tokyo, Japan, 150-8935
Shinjuku-ku, Tokyo, Japan, 160-0023
Shimonoseki, Yamaguchi, Japan, 750-0061
Ube, Yamaguchi, Japan, 755-8505
Kofu, Yamanashi, Japan, 400-8506
Chiba, Japan, 260-0856
Fukuoka, Japan, 810-8563
Fukuoka, Japan, 814-0180
Gifu, Japan, 500-8513
Gifu, Japan, 501-1194
Hiroshima, Japan, 734-8530
Hiroshima, Japan, 734-8551
Kagoshima, Japan, 890-8520
Kumamoto, Japan, 860-0811
Nagasaki, Japan, 852-8501
Niigata, Japan, 950-1104
Oita, Japan, 879-5593
Okayama, Japan, 700-8558
Osaka, Japan, 534-0021
Osaka, Japan, 537-8511
Osaka, Japan, 540-0006
Osaka, Japan, 543-8555
Osaka, Japan, 545-8586
Saga, Japan, 840-8571
Saga, Japan, 849-8501
Tokushima, Japan, 770-8503
Tokushima, Japan, 770-8539
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Kowa Company, Ltd.

Responsible Party: Kowa Company, Ltd. Identifier: NCT01640808     History of Changes
Other Study ID Numbers: NIK-333-05
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Liver Neoplasms
Disease Attributes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases