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

An observational study of Hepatitis C, run by Gilead Sciences at 125 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
What is being tested?: Harvoni
Type of treatment: Pill or oral medicine
How many people: 3,294 participants
Where: 125 sitesJapan
Study dates: 30 Nov 2015to 1 Nov 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

None
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

125 sites in 1 country.

City, postcode or hospital

125 sites in 1 country

Japan125 sites

Study site
Ageo-shi
Study site
Akita
Study site
Amagasaki-shi
Study site
Aomori
Study site
Arao-shi
Study site
Asahi-shi
Study site
Asahikawa-shi
Study site
Asakura-shi
Study site
Bunkyō City
Study site
Chiba
Study site
Chichibu-shi
Study site
Chuo-shi
Study site
Fujioka-shi
Study site
Fukui-shi
Study site
Fukuoka
Study site
Gifu
Study site
Hakodate-shi
Study site
Hamamatsu
Study site
Handa-shi
Study site
Hashima-shi
Study site
Hatsukaichi-shi
Study site
Higashiibaraki-gun
Study site
Hirosaki-shi
Study site
Hiroshima
Study site
Hitachi-shi
Study site
Hukui-shi
Study site
Ichikawa-shi
Study site
Iizuka-shi
Study site
Ikeda-shi
Study site
Inashiki-gun
Study site
Inzai-shi
Study site
Iruma-gun
Study site
Ise-shi
Study site
Iwaki
Study site
Izumo-shi
Study site
Izunokuni-shi
Study site
Kagoshima
Study site
Kamogawa-shi
Study site
Kanazawa
Study site
Karatsu-shi
Study site
Kashihara-shi
Study site
Kashiwa-shi
Study site
Kasukabe-shi
Study site
Kawagoe-shi
Study site
Kawaguchi-shi
Study site
Kawasaki-shi
Study site
Kirishima-shi
Study site
Kitakyushu-shi
Study site
Kitamoto-shi
Study site
Kobe
Study site
Kodaira-shi
Study site
Kofu
Study site
Komae-shi
Study site
Komaki-shi
Study site
Koriyama-shi
Study site
Koshigaya-shi
Study site
Kōtoku
Study site
Kuga-gun
Study site
Kuki-shi
Study site
Kumamoto
Study site
Kurashiki-shi
Study site
Kure-shi
Study site
Kurume-shi
Study site
Kyoto
Study site
Maebashi
Study site
Matsumoto-shi
Study site
Matsuyama
Study site
Minatoku
Study site
Miyazaki
Study site
Moriguchi-shi
Study site
Morioka
Study site
Nagakute-shi
Study site
Nagasaki
Study site
Nagoya
Study site
Nakagami-gun
Study site
Nerima-ku
Study site
Niigata
Study site
Nishinomiya-shi
Study site
Noshiro
Study site
Obihiro-shi
Study site
Ofukeshi
Study site
Ōita
Study site
Okayama
Study site
Ōmihachiman
Study site
Osaka
Study site
Osakasayama-shi
Study site
Ōta-ku
Study site
Ōtsu
Study site
Oume-shi
Study site
Saga
Study site
Saitama-shi
Study site
Sakaishi
Study site
Sano-shi
Study site
Sapporo
Study site
Sasebo-Shi
Study site
Sendai
Study site
Shimonoseki-shi
Study site
Shimotsuga-gun
Study site
Shimotsuke-shi
Study site
Shinagawa-ku
Study site
Shinjuku-ku
Study site
Shirakawa-shi
Study site
Shizuoka
Study site
Shunan-shi
Study site
Sumida-ku
Study site
Tagawa-shi
Study site
Takamatsu
Study site
Takasaki-shi
Study site
Toda-shi
Study site
Tokorozawa-shi
Study site
Tokushima
Study site
Tonami-shi
Study site
Toyama
Study site
Toyoake-shi
Study site
Ureshino-shi
Study site
Utsunomiya
Study site
Wakayama
Study site
Yachiyo-shi
Study site
Yamagata
Study site
Yanagawa-shi
Study site
Yatsushiro-shi
Study site
Yokkaichi-shi
Study site
Yokohama
Study site
Yonago-shi
Study site
Yoshida-gun

Other trials in Japan

About this study

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

Conditions: Hepatitis C
Being tested: Harvoni
Keywords: Hepatitis C virus, observational, post-marketing, ledipasvir/sofosbuvir, Japan
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HarvoniDrug
Also called LDV/SOF, GS-5885/GS-7977
Harvoni (90/400 mg) FDC tablet administered orally once daily

Study groups in NCT02591277
Study group	Role	What they receive
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. Receives: Drug: Harvoni

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
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.
Measured: Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Measured: Approximately 12 weeks after treatment completion or discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 20151 Nov 2017

First posted29 Oct 2015 (estimated)
Study start30 Nov 2015
Primary completion1 Nov 2017
Study completion1 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Ecologic or community
Time perspective: Prospective
Enrolment: 3,294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02591277
Sponsor's protocol ID: GS-US-337-1498
Status last verified: Feb 2019
First submitted: 28 Oct 2015
Last updated: 6 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Mizokami M, Liu LJ, Fujiyama N, Littman M, Yuan J, Sekiya T, Hedskog C, Ng LJ. Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan. J Viral Hepat. 2021 Jan;28(1):129-141. doi: 10.1111/jvh.13395. Epub 2020 Sep 16.
PubMed 32869924

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT02591277
Acronym / sponsor ID: GS-US-337-1498
Conditions: Hepatitis C
Keywords: Hepatitis C virus, observational, post-marketing, ledipasvir/sofosbuvir, Japan
Study type: Observational
Recruitment status: Completed
Enrolment: 3,294 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 30 Nov 2015 (actual)
Primary completion: 1 Nov 2017 (actual)
Study completion: 1 Nov 2017 (actual)
First posted: 29 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Ecologic or community
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Harvoni	–	Drug: HarvoniAdult 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

None
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HarvoniAlso: LDV/SOF, GS-5885/GS-7977Harvoni (90/400 mg) FDC tablet administered orally once daily	Drug	Harvoni

Primary outcome

Incidence of adverse drug reaction (ADR) under real world settings
Time frame: Up to 16 weeks

2 secondary outcomes

Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
Time frame: Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Time frame: Approximately 12 weeks after treatment completion or discontinuation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
Derived from this study: PubMed 32869924Mizokami M, Liu LJ, Fujiyama N, Littman M, Yuan J, Sekiya T, Hedskog C, Ng LJ. Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan. J Viral Hepat. 2021 Jan;28(1):129-141. doi: 10.1111/jvh.13395. Epub 2020 Sep 16.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

125 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by Gilead Sciences at 125 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse drug reaction (ADR) under real world settings (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02591277, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.