Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
NCT ID: NCT02537379
Last Updated: 2017-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
552 participants
OBSERVATIONAL
2015-09-15
2017-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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SOF+COPE
Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+COPE as part of routine clinical care at a participating clinical site.
SOF
SOF 400 mg tablets administered orally once daily
COPE
COPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)
Interventions
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SOF
SOF 400 mg tablets administered orally once daily
COPE
COPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are prescribed SOF+COPE
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Amagasaki-shi, , Japan
Asahi-shi, , Japan
Asahikawa-shi, , Japan
Beppu-shi, , Japan
Chichibu-shi, , Japan
Fujioka-shi, , Japan
Fukui-shi, , Japan
Hamamatsu, , Japan
Iizuka-shi, , Japan
Inzai-shi, , Japan
Ishinomaki-shi, , Japan
Iwaki, , Japan
Izunokuni-shi, , Japan
Kahoku-gun, , Japan
Kanazawa, , Japan
Kirishima-shi, , Japan
Kisarazu-shi, , Japan
Kitamoto-shi, , Japan
Kobe, , Japan
Koshigaya-shi, , Japan
Kure-shi, , Japan
Moriguchi-shi, , Japan
Nagakute-shi, , Japan
Nagaoka-shi, , Japan
Nagasaki, , Japan
Nagoya, , Japan
Nakagami-gun, , Japan
Nanto-shi, , Japan
Nishinomiya-shi, , Japan
Ofukeshi, , Japan
Okayama, , Japan
Ome-shi, , Japan
Osaka, , Japan
Ōta-ku, , Japan
Sapporo, , Japan
Sasebo-Shi, , Japan
Sendai, , Japan
Shinagawa-ku, , Japan
Shinjuku-ku, , Japan
Tokorozawa-shi, , Japan
Tokushima, , Japan
Wakayama, , Japan
Yachiyo-shi, , Japan
Yokohama, , Japan
Yufu-shi, , Japan
Countries
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Other Identifiers
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GS-US-334-1444 / COPE1501
Identifier Type: -
Identifier Source: org_study_id
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