Phase 2
Completed N=70
CTS-1027 in Interferon-Naive Hepatitis C Patients
Source: ClinicalTrials.gov NCT00925990 ↗Enrolled (actual)
70
Serious AEs
12.9%
Results posted
Mar 2012
Primary outcomePrimary: Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment — -0.48; -0.12 log (IU/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment |
-0.48; -0.12 | — |
| SECONDARY Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment |
-15.6; -16.5 | — |
Eligibility 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) 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:
- Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00925990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.