CTS-1027 in Interferon-Naive Hepatitis C Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00925990
First received: June 19, 2009
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Hepatitis C
Drug: ribavirin
Drug: CTS-1027
Drug: Placebo for ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients

Resource links provided by NLM:


Further study details as provided by Conatus Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]

    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:
  • Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]

    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)



Enrollment: 70
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925990

  Show 21 Study Locations
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Investigators
Study Chair: Erin Castelloe, MD Conatus Pharmaceuticals
  More Information

No publications provided

Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00925990     History of Changes
Other Study ID Numbers: CTS-1027-03
Study First Received: June 19, 2009
Results First Received: February 9, 2012
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Conatus Pharmaceuticals Inc.:
HCV
interferon-naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014