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CTS-1027 in Interferon-Naive Hepatitis C Patients

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ClinicalTrials.gov Identifier: NCT00925990
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE June 19, 2009
First Posted Date  ICMJE June 23, 2009
Results First Submitted Date  ICMJE February 9, 2012
Results First Posted Date  ICMJE March 27, 2012
Last Update Posted Date March 27, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ]
Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood from before treatment (baseline) through 24 weeks of treatment. Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
Changes in mean HCV-RNA levels from baseline [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT00925990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ]
Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented. Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
Mean change in aminotransferases from baseline [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CTS-1027 in Interferon-Naive Hepatitis C Patients
Official Title  ICMJE A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
Brief Summary The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.
Detailed Description

There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment.

This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: ribavirin
    200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks
    Other Name: Copegus
  • Drug: CTS-1027
    5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks
  • Drug: Placebo for ribavirin
    Capsules identical to ribavirin in appearance containing inactive ingredients
Study Arms  ICMJE
  • Experimental: CTS-1027 + ribavirin
    Study drug plus ribavirin
    Interventions:
    • Drug: ribavirin
    • Drug: CTS-1027
  • Experimental: CTS-1027 + placebo
    Study drug plus placebo for ribavirin
    Interventions:
    • Drug: CTS-1027
    • Drug: Placebo for ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2009)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial
  • A history of chronic (> 6 months duration) genotype 1 Hepatitis C (HCV) infection
  • Unsuitable for interferon-based HCV treatment, defined as at least one of the following three criteria:

    • Contra-indicated for interferon treatment due to current or prior psychiatric disorders
    • Patient's decision to not pursue interferon-based therapy
    • In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon-based therapy
  • a-fetoprotein (AFP) <= 50 ng/mL
  • Hemoglobin ≥ 12 g/dL, platelet count ≥ 100 x 109/L, and white blood cell count ≥ 1.5 x 109/L
  • Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the trial.

Exclusion Criteria:

  • Decompensated or severe liver disease defined by one or more of the following criteria:

    • Prothrombin time 3 seconds > control
    • Direct bilirubin ≥ 1.5 x upper limit of normal range (ULN)
    • Serum albumin below normal limits
    • AST or ALT > 7 x ULN at screening
    • Evidence of portal hypertension including:

      1. Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
      2. Ascites
  • Cirrhosis defined by one or both of the following criteria:

    • Liver biopsy showing cirrhosis
    • Other clinical signs and symptoms suggestive of cirrhosis
  • Prior therapy for HCV with an interferon-based regimen
  • Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
  • Known history or presence of human immunodeficiency virus (HIV) infection
  • Co-infection with hepatitis B virus (HBV)
  • If female: pregnant, lactating, or positive serum pregnancy test
  • Renal impairment (creatinine > 1.5 x ULN), creatinine clearance < 50 mL/min, or hepatorenal syndrome
  • Hospitalization for liver disease within 60 days of screening
  • Use of concomitant or prior drug therapy for HCV three months prior to screening
  • Use of drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
  • History of alcohol abuse (> 50 g per day) within the past year
  • History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QT or QTc interval of > 450 milliseconds
  • Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for ten or more years
  • Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00925990
Other Study ID Numbers  ICMJE CTS-1027-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Conatus Pharmaceuticals Inc.
Study Sponsor  ICMJE Conatus Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Erin Castelloe, MD Conatus Pharmaceuticals
PRS Account Conatus Pharmaceuticals Inc.
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP