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Clinical trialNCT01273064TerminatedPhase 2Interventional

Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders

SponsorConatus Pharmaceuticals Inc.Enrollment114Hepatitis C
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies). Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels after 12 weeks of treatment (know as an "early virologic response", or EVR) during previous SOC therapy. If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week 12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that patient is not a null-responder, and is excluded from study participation. If, during previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must have been \< 2 log decline (and still HCV-RNA positive) in order for the patient to be defined as a null-responder. Patients will be screened and have up to 4 weeks to qualify for study entry. During this screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients will undergo centralized, stratified (based on ethnicity), randomization to one of four treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo patients who do not show a virologic response after 12 weeks of therapy will be rolled onto SOC + 15mg CTS-1027, while maintaining the study blind.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

45 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Southern California Liver Centers

    Coronado, California, United States

  • Scripps Clinic

    La Jolla, California, United States

  • Loma Linda University Mc

    Loma Linda, California, United States

  • Huntington Medical Research Institute

    Pasadena, California, United States

  • Medical Associates Research Group

    San Diego, California, United States

  • Ucsd

    San Diego, California, United States

  • University of Colorado Denver

    Aurora, Colorado, United States

  • Yale University School of Medicine

    New Haven, Connecticut, United States

  • University of Miami

    Miami, Florida, United States

  • Atlanta Medical Center, Inc.

    Atlanta, Georgia, United States

  • Liver Center of Atlanta

    Atlanta, Georgia, United States

  • Rush University Medical Center

    Chicago, Illinois, United States

  • Loyola University

    Maywood, Illinois, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, United States

  • University of Louisville

    Louisville, Kentucky, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, United States

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, United States

  • Henry Ford Hospital

    Detroit, Michigan, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • St. Louis University

    St Louis, Missouri, United States

  • Columbia Presbyterian Medical Center

    New York, New York, United States

  • Concorde Medical Group

    New York, New York, United States

  • New York University

    New York, New York, United States

  • Weill Medical College of Cornell

    New York, New York, United States

  • Einstein College of Medicine (jacobi Medical Center)

    The Bronx, New York, United States

  • New York Medical College

    Valhalla, New York, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • Consultants for Clinical Research

    Cincinnati, Ohio, United States

  • Cleveland Clinic

    Cleveland, Ohio, United States

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, United States

  • Baylor All Saints Medical Center

    Fort Worth, Texas, United States

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, United States

  • Research Specialists of Texas

    Houston, Texas, United States

  • St. Luke'S Episcopal Hospital

    Houston, Texas, United States

  • University of Texas Hsc at Houston

    Houston, Texas, United States

  • Vamc Houston

    Houston, Texas, United States

5 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CTS-1027PlaceboRibavirin →Pegylated interferon
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2011
Primary completion
30 Sept 2011
Completion
31 Oct 2011
Last update posted
11 Jun 2012
Registered enrollment
114
Registry id
NCT01273064

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.