CTS-1027 in Interferon-Naive Hepatitis C Patients
A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
1 other identifier
interventional
70
2 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
March 27, 2012
CompletedMarch 27, 2012
February 1, 2012
11 months
June 19, 2009
February 9, 2012
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
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)
Baseline and 24 weeks
Secondary Outcomes (1)
Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
Baseline and 24 weeks
Study Arms (2)
CTS-1027 + ribavirin
EXPERIMENTALStudy drug plus ribavirin
CTS-1027 + placebo
EXPERIMENTALStudy drug plus placebo for ribavirin
Interventions
200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks
5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks
Capsules identical to ribavirin in appearance containing inactive ingredients
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- 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)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Kaiser Permanante
San Diego, California, 92154, United States
VA Medical Center, San Diego
San Diego, California, 92161, United States
University of Colorado Health Science Center
Denver, Colorado, 80262, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainsville, Florida, 32610, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of MA Mem Med Ctr
Worchester, Massachusetts, 01655, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
MN Clinical Research Center
Plymouth, Minnesota, 55446, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
St. Louis University
St Louis, Missouri, 63104, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of NC at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Health System
Durham, North Carolina, 27710, United States
Consultants of Clinical Research, Ohio GI and Liver Institute
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
VA Medical Center, Houston
Houston, Texas, 77030, United States
VCU-Medical College of Virginia
Richmond, Virginia, 23298, United States
Fundacion de Investigacion de Diego
Santurce, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Development
- Organization
- Conatus Pharmaceuticals Inc.
Study Officials
- STUDY CHAIR
Erin Castelloe, MD
Conatus Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 23, 2009
Study Start
June 1, 2009
Primary Completion
May 1, 2010
Study Completion
July 1, 2010
Last Updated
March 27, 2012
Results First Posted
March 27, 2012
Record last verified: 2012-02