Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT02591277

Collaborator

(none)

3,294

Enrollment

125

Locations

23.1

Actual Duration (Months)

26.4

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Harvoni

Study Design

Study Type:

Observational

Actual Enrollment :

3294 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection

Actual Study Start Date :

Nov 30, 2015

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Harvoni Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.	Drug: Harvoni Harvoni (90/400 mg) FDC tablet administered orally once daily Other Names: LDV/SOF GS-5885/GS-7977

Arm

Intervention/Treatment

Harvoni

Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.

Drug: Harvoni

Harvoni (90/400 mg) FDC tablet administered orally once daily

Other Names:

LDV/SOF

GS-5885/GS-7977

Outcome Measures

Primary Outcome Measures

Incidence of adverse drug reaction (ADR) under real world settings [Up to 16 weeks]

Secondary Outcome Measures

Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24) [Posttreatment Weeks 12 and 24]
SVR12 and SVR24 are defined as HCV RNA < the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.
Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks [Approximately 12 weeks after treatment completion or discontinuation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis
Patients who are prescribed Harvoni

Key Exclusion Criteria:

None

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	City	Country
1	Ageo-shi	Japan
2	Akita-shi	Japan
3	Amagasaki-shi	Japan
4	Aomori-shi	Japan
5	Arao-shi	Japan
6	Asahi-shi	Japan
7	Asahikawa-shi	Japan
8	Asakura-shi	Japan
9	Bunkyo-ku	Japan
10	Chiba-shi	Japan
11	Chichibu-shi	Japan
12	Chuo-shi	Japan
13	Fujioka-shi	Japan
14	Fukui-shi	Japan
15	Fukuoka-shi	Japan
16	Gifu-shi	Japan
17	Hakodate-shi	Japan
18	Hamamatsu-shi	Japan
19	Handa-shi	Japan
20	Hashima-shi	Japan
21	Hatsukaichi-shi	Japan
22	Higashiibaraki-gun	Japan
23	Hirosaki-shi	Japan
24	Hiroshima-shi	Japan
25	Hitachi-shi	Japan
26	Hukui-shi	Japan
27	Ichikawa-shi	Japan
28	Iizuka-shi	Japan
29	Ikeda-shi	Japan
30	Inashiki-gun	Japan
31	Inzai-shi	Japan
32	Iruma-gun	Japan
33	Ise-shi	Japan
34	Iwaki-shi	Japan
35	Izumo-shi	Japan
36	Izunokuni-shi	Japan
37	Kagoshima-shi	Japan
38	Kamogawa-shi	Japan
39	Kanazawa-shi	Japan
40	Karatsu-shi	Japan
41	Kashihara-shi	Japan
42	Kashiwa-shi	Japan
43	Kasukabe-shi	Japan
44	Kawagoe-shi	Japan
45	Kawaguchi-shi	Japan
46	Kawasaki-shi	Japan
47	Kirishima-shi	Japan
48	Kitakyushu-shi	Japan
49	Kitamoto-shi	Japan
50	Kobe-shi	Japan
51	Kodaira-shi	Japan
52	Kofu-shi	Japan
53	Komae-shi	Japan
54	Komaki-shi	Japan
55	Koriyama-shi	Japan
56	Koshigaya-shi	Japan
57	Koto-ku	Japan
58	Kuga-gun	Japan
59	Kuki-shi	Japan
60	Kumamoto-shi	Japan
61	Kurashiki-shi	Japan
62	Kure-shi	Japan
63	Kurume-shi	Japan
64	Kyoto-shi	Japan
65	Maebashi-shi	Japan
66	Matsumoto-shi	Japan
67	Matsuyama-shi	Japan
68	Minato-ku	Japan
69	Miyazaki-shi	Japan
70	Moriguchi-shi	Japan
71	Morioka-shi	Japan
72	Nagakute-shi	Japan
73	Nagasaki-shi	Japan
74	Nagoya-shi	Japan
75	Nakagami-gun	Japan
76	Nerima-ku	Japan
77	Niigata-shi	Japan
78	Nishinomiya-shi	Japan
79	Noshiro-shi	Japan
80	Obihiro-shi	Japan
81	Ogi-shi	Japan
82	Oita-shi	Japan
83	Okayama-shi	Japan
84	Omihachiman-shi	Japan
85	Osaka-shi	Japan
86	Osakasayama-shi	Japan
87	Ota-ku	Japan
88	Otsu-shi	Japan
89	Oume-shi	Japan
90	Saga-shi	Japan
91	Saitama-shi	Japan
92	Sakai-shi	Japan
93	Sano-shi	Japan
94	Sapporo-shi	Japan
95	Sasebo-Shi	Japan
96	Sendai-shi	Japan
97	Shimonoseki-shi	Japan
98	Shimotsuga-gun	Japan
99	Shimotsuke-shi	Japan
100	Shinagawa-ku	Japan
101	Shinjuku-ku	Japan
102	Shirakawa-shi	Japan
103	Shizuoka-shi	Japan
104	Shunan-shi	Japan
105	Sumida-ku	Japan
106	Tagawa-shi	Japan
107	Takamatsu-shi	Japan
108	Takasaki-shi	Japan
109	Toda-shi	Japan
110	Tokorozawa-shi	Japan
111	Tokushima-shi	Japan
112	Tonami-shi	Japan
113	Toyama-shi	Japan
114	Toyoake-shi	Japan
115	Ureshino-shi	Japan
116	Utsunomiya-shi	Japan
117	Wakayama-shi	Japan
118	Yachiyo-shi	Japan
119	Yamagata-shi	Japan
120	Yanagawa-shi	Japan
121	Yatsushiro-shi	Japan
122	Yokkaichi-shi	Japan
123	Yokohama-shi	Japan
124	Yonago-shi	Japan
125	Yoshida-gun	Japan