We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CTS-1027-03
Previous Study | Return to List | Next Study

CTS-1027 in Interferon-Naive Hepatitis C Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00925990
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: ribavirin Drug: CTS-1027 Drug: Placebo for ribavirin Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CTS-1027 + ribavirin
Study drug plus ribavirin
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

Experimental: CTS-1027 + placebo
Study drug plus placebo for ribavirin
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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925990

Show Show 21 study locations
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Layout table for investigator information
Study Chair: Erin Castelloe, MD Conatus Pharmaceuticals
Layout table for additonal information
Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00925990    
Other Study ID Numbers: CTS-1027-03
First Posted: June 23, 2009    Key Record Dates
Results First Posted: March 27, 2012
Last Update Posted: March 27, 2012
Last Verified: February 2012
Keywords provided by Conatus Pharmaceuticals Inc.:
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents