CTS-1027 in Interferon-Naive Hepatitis C Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00925990
• Date of registration: 19/06/2009
• Primary sponsor: Conatus Pharmaceuticals Inc.
• Public title: CTS-1027 in Interferon-Naive Hepatitis C Patients
• Scientific title: A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
• Date of first enrolment: June 2009
• Target sample size: 70
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00925990
• 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

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: Erin Castelloe, MD
• Affiliation: Conatus Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: CTS-1027

Drug: Placebo for ribavirin

Drug: ribavirin

Primary Outcome(s)

Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment [Time Frame: Baseline and 24 weeks]

Secondary Outcome(s)

Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment [Time Frame: Baseline and 24 weeks]

Secondary ID(s)

CTS-1027-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors