Trials / Completed
CompletedNCT01640808
Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC
NIK-333(Peretinoin) PhaseⅢ Study 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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 616 (actual)
- Sponsor
- Kowa Company, Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NIK-333(peretinoin) | 600mg (8 x 75mg capsules) orally, twice a day |
| DRUG | Placebo | Placebo (8 x Placebo capsules) orally, twice a day |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2016-10-01
- Completion
- 2016-11-01
- First posted
- 2012-07-16
- Last updated
- 2020-12-02
- Results posted
- 2020-12-02
Locations
66 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01640808. Inclusion in this directory is not an endorsement.