HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

NCT01474811 | Completed

• 1 other identifier: 11-1991
• Study Type: observational
• Target: 13,559
• Locations: 4 countries
• Sites: 60

Brief Summary

The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.

Conditions

Hepatitis C

Keywords

Hepatitis; Hepatitis C; HCV-TARGET; HCV; Observational Study

Outcome Measures

Primary Outcomes (1)

• Sustained virological response (SVR)

  The primary outcome measure is the occurence (yes or no) of SVR, defined as undetectable HCV RNA in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various sub-populations enrolled in HCV-TARGET.

  24 months

Secondary Outcomes (3)

• Treatment persistence

  24 months

• Virological breakthrough

  24 months

• Management of adverse events

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female adult patients: Aged 18 and older with chronic HCV treated with triple therapy (including protease inhibitors).

You may qualify if:

• All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens that contain telaprevir or boceprevir.

You may not qualify if:

• Inability to provide written informed consent.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Florida: collaborator

Study Sites (60)

Mayo Clinic AZ

Phoenix, Arizona, 85054, United States

Location

Liver Wellness Center

Little Rock, Arkansas, 72205, United States

Location

Scripps

La Jolla, California, 92037, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

UCSF/San Fran General Hospital

San Francisco, California, 94110, United States

Location

Univ of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado, Denver

Denver, Colorado, 80045, United States

Location

Yale University Digestive Diseases

New Haven, Connecticut, 06520, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Atlanta Medical Center

Atlanta, Georgia, 30312, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Lake Shore Gastroenterology & Liver Disease Inst.

Chicago, Illinois, 60016, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

John Hopkins University

Lutherville, Maryland, 21093, United States

Location

Massachussets General Hospital

Boston, Massachusetts, 02114, United States

Location

Harvard University/ Beth Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minnesota Gastro

Minneapolis, Minnesota, 55455, United States

Location

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi

Oxford, Mississippi, 38677, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

University of Nebraska Medical Ctr

Omaha, Nebraska, 68105, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Southwest CARE Center

Santa Fe, New Mexico, 87505, United States

Location

Hudson River Healthcare

Beacon, New York, 12508, United States

Location

North Shore Hospital

Manhasset, New York, 11030, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mountain View Medical Center

Valatie, New York, 12184, United States

Location

Asheville Gastroenterology Assoc

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

PMG Research of Rocky Mount, LLC

Rocky Mount, North Carolina, 27804, United States

Location

Trial Management Associates (TMA)

Wilmington, North Carolina, 28403, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Austin Hepatitis Center

Austin, Texas, 78758, United States

Location

MetaClin Research, Inc

Austin, Texas, 78758, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Research Specialist of Texas

Houston, Texas, 77030, United States

Location

Metropolitan Liver Diseases and Gastroenterology

Annandale, Virginia, 22003, United States

Location

Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)

Richmond, Virginia, 23226, United States

Location

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Liver Clinic, Toronto Western Hospital, UHN

Toronto, Ontario, M5T 2S8, Canada

Location

RWTH University Hospital

Aachen, Germany

Location

J. W. Goethe University Hospital

Frankfurt, DE-60590, Germany

Location

Hanover Medical School

Hanover, Germany

Location

Fundacion de investigacion de Diego

San Juan, 00927, Puerto Rico

Location

Related Publications (7)

• Verna EC, Morelli G, Terrault NA, Lok AS, Lim JK, Di Bisceglie AM, Zeuzem S, Landis CS, Kwo P, Hassan M, Manns MP, Vainorius M, Akushevich L, Nelson DR, Fried MW, Reddy KR. DAA therapy and long-term hepatic function in advanced/decompensated cirrhosis: Real-world experience from HCV-TARGET cohort. J Hepatol. 2020 Sep;73(3):540-548. doi: 10.1016/j.jhep.2020.03.031. Epub 2020 Mar 31.

  PMID: 32243960 DERIVED

• Reddy KR, Lim JK, Kuo A, Di Bisceglie AM, Galati JS, Morelli G, Everson GT, Kwo PY, Brown RS Jr, Sulkowski MS, Akuschevich L, Lok AS, Pockros PJ, Vainorius M, Terrault NA, Nelson DR, Fried MW, Manns MP; HCV-TARGET Study Group. All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database. Aliment Pharmacol Ther. 2017 Jan;45(1):115-126. doi: 10.1111/apt.13823. Epub 2016 Oct 28.

  PMID: 27790729 DERIVED

• Terrault NA, Zeuzem S, Di Bisceglie AM, Lim JK, Pockros PJ, Frazier LM, Kuo A, Lok AS, Shiffman ML, Ben Ari Z, Akushevich L, Vainorius M, Sulkowski MS, Fried MW, Nelson DR; HCV-TARGET Study Group. Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response. Gastroenterology. 2016 Dec;151(6):1131-1140.e5. doi: 10.1053/j.gastro.2016.08.004. Epub 2016 Aug 24.

  PMID: 27565882 DERIVED

• Welzel TM, Nelson DR, Morelli G, Di Bisceglie A, Reddy RK, Kuo A, Lim JK, Darling J, Pockros P, Galati JS, Frazier LM, Alqahtani S, Sulkowski MS, Vainorius M, Akushevich L, Fried MW, Zeuzem S; HCV-TARGET Study Group. Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study. Gut. 2017 Oct;66(10):1844-1852. doi: 10.1136/gutjnl-2016-311609. Epub 2016 Jul 13.

  PMID: 27418632 DERIVED

• Saxena V, Koraishy FM, Sise ME, Lim JK, Schmidt M, Chung RT, Liapakis A, Nelson DR, Fried MW, Terrault NA; HCV-TARGET. Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function. Liver Int. 2016 Jun;36(6):807-16. doi: 10.1111/liv.13102. Epub 2016 Mar 24.

  PMID: 26923436 DERIVED

• Sulkowski MS, Vargas HE, Di Bisceglie AM, Kuo A, Reddy KR, Lim JK, Morelli G, Darling JM, Feld JJ, Brown RS, Frazier LM, Stewart TG, Fried MW, Nelson DR, Jacobson IM; HCV-TARGET Study Group. Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection. Gastroenterology. 2016 Feb;150(2):419-29. doi: 10.1053/j.gastro.2015.10.013. Epub 2015 Oct 21.

  PMID: 26497081 DERIVED

• Sterling RK, Kuo A, Rustgi VK, Sulkowski MS, Stewart TG, Fenkel JM, El-Genaidi H, Mah'moud MA, Abraham GM, Stewart PW, Akushevich L, Nelson DR, Fried MW, Di Bisceglie AM. Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir. Aliment Pharmacol Ther. 2015 Apr;41(7):671-85. doi: 10.1111/apt.13095. Epub 2015 Jan 28.

  PMID: 25627020 DERIVED

Related Links

• Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir.
• Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.
• Safety and Efficacy of Sofosbuvir-Containing Regimens in Hepatitis C Infected Patients with Impaired Renal Function.
• Interferon-free therapy for genotype 1 hepatitis C in liver transplant recipients: Real-world experience from the hepatitis C therapeutic registry and research network.
• Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection.
• Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated of Sustained Virologic Response.
• Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.
• Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study.
• Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis
• Safety and efficacy of current direct-acting antiviral regimens in kidney and liver transplant recipients with hepatitis C: Results from the HCV-TARGET study
• All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database
• Public-Private Partnership: Targeting Real-World Data for Hepatitis C Direct-Acting Antivirals.
• Treatment Status of Hepatocellular Carcinoma Does Not Influence Rates of Sustained Virologic Response: An HCV-TARGET Analysis
• Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy

Biospecimen

Retention: SAMPLES WITH DNA

All patients will be invited to participate in the HCV-TARGET Biorepository Specimen Bank (BSB). The following will be collected: Blood (Serum and DNA). All samples will be collected on a voluntary basis and participation in this project will not affect participation in the main study. Samples collected will be stored at the University of Florida for up to 15 years after the end of the study (database closure) at which time they will be destroyed. The implementation and use of the BSB specimens is governed by the University of Florida Biospecimen Repository policy to ensure the appropriate use of the deposited samples.

MeSH Terms

Conditions

Hepatitis C; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Study Officials

• Michael W. Fried, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• David R. Nelson, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 18, 2011
• Study Start: November 1, 2011
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (55); CA (1); DE (3); PR (1)