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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR HARVONI

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Clinical Trials for Harvoni

Trial ID Title Status Sponsor Phase Summary
NCT01987453 Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study Completed Gilead Sciences Phase 2 This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).
NCT02339038 Study to Assess Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia Active, not recruiting National Institutes of Health Clinical Center (CC) Phase 4 Background: - Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia. Objectives: - To see if people can be treated for Hepatitis C safely and successfully in community-based health centers. Eligibility: - Adults who need treatment for chronic Hepatitis C infection. Design: - Participants will be screened with blood tests. Their current medicines will be reviewed. - Participants will give researchers access to their medical records. Researchers will follow participants through these records. - Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits. - Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly. - Participants will have monthly follow-up visits for up to 3 months after they finish their medicine. - Participants will have yearly follow-up visits with their care provider for up to 10 years.
NCT02347345 Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs Active, not recruiting National Institute on Drug Abuse (NIDA) Phase 4 The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studied healthy volunteers.This is based on observations that this group of investigators have made. They have shown that individuals who inject drugs have high level of immune activation in blood and tissue. Immune activation or chronic inflammation has been associated with accelerated aging, cardiovascular, renal and liver disease as well as CNS dysfunction. It remains unclear whether increased levels of immune activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C, chronic opiate use, or perhaps combinations of all 3. To understand the potential contribution of infection with Hepatitis C the investigators will compare levels of immune activation pre- and post treatment with an all oral, one pill once daily, interferon sparing treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting with drugs and the other free of injection for at least 4 months. Immune activation comparisons will also include non-injecting healthy volunteers.
NCT02347345 Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs Active, not recruiting Rockefeller University Phase 4 The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studied healthy volunteers.This is based on observations that this group of investigators have made. They have shown that individuals who inject drugs have high level of immune activation in blood and tissue. Immune activation or chronic inflammation has been associated with accelerated aging, cardiovascular, renal and liver disease as well as CNS dysfunction. It remains unclear whether increased levels of immune activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C, chronic opiate use, or perhaps combinations of all 3. To understand the potential contribution of infection with Hepatitis C the investigators will compare levels of immune activation pre- and post treatment with an all oral, one pill once daily, interferon sparing treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting with drugs and the other free of injection for at least 4 months. Immune activation comparisons will also include non-injecting healthy volunteers.
NCT02480166 Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6 Completed Gilead Sciences Phase 4 The primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 2. 12-week treatment of SOF/LED for all other HCV-6 populations
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Harvoni

Condition Name

Condition Name for Harvoni
Intervention Trials
Hepatitis C 13
Chronic Hepatitis C 5
Hepatitis C, Chronic 3
Human Immunodeficiency Virus 2
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Condition MeSH

Condition MeSH for Harvoni
Intervention Trials
Hepatitis C 28
Hepatitis 27
Hepatitis A 20
Hepatitis C, Chronic 12
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Clinical Trial Locations for Harvoni

Trials by Country

Trials by Country for Harvoni
Location Trials
United States 80
Italy 6
Canada 3
Spain 2
Japan 1
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Trials by US State

Trials by US State for Harvoni
Location Trials
New York 8
California 8
Texas 6
Maryland 6
Pennsylvania 5
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Clinical Trial Progress for Harvoni

Clinical Trial Phase

Clinical Trial Phase for Harvoni
Clinical Trial Phase Trials
Phase 4 14
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Harvoni
Clinical Trial Phase Trials
Recruiting 18
Not yet recruiting 7
Completed 5
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Clinical Trial Sponsors for Harvoni

Sponsor Name

Sponsor Name for Harvoni
Sponsor Trials
Gilead Sciences 14
University of Maryland 4
National Taiwan University Hospital 2
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Sponsor Type

Sponsor Type for Harvoni
Sponsor Trials
Other 51
Industry 18
NIH 7
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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Federal Trade Commission
AstraZeneca
McKinsey
Fish and Richardson
Dow
Teva
Johnson and Johnson

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