Status:
COMPLETED
A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1
Lead Sponsor:
Can-Fite BioPharma
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
This trial will test the hypothesis that CF102 can safely and effectively suppress viral load in patients with chronic hepatitis C and high circulating levels of virus. The trial will monitor the safe...
Detailed Description
This is a Phase 1/2, randomized, double-blind, placebo-controlled, dose-escalation study of subjects with chronic hepatitis C genotype 1. Eligible subjects will be assigned in a 3:1 ratio (8 subjects ...
Eligibility Criteria
Inclusion
- 18 to 60 years of age
- Body mass index ≤ 30 kg/m2
- Either:
- no evidence of cirrhosis, or liver fibrosis corresponding to Metavir Stages 0 to 31 on a liver biopsy performed within the past 2 years, or
- a score of F0 or F1 on ActiTest-FibroTest performed within the past year.
- Child-Pugh score ≤ 5 at Screening
- Serologic evidence of chronic hepatitis C-infection (anti-HCV in serum)
- HCV plasma RNA ≥ 1 x 105 IU/mL on 2 separate samples obtained during the screening period.
- HCV genotype 1
- The following laboratory values must be documented within the Screening period:
- Hemoglobin \> 11.0 g/dL for females and \> 12.0 g/dL for males
- Platelet count \> 50 x109/L
- Normal serum creatinine
- Aspartic aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5-fold the upper limit of normal
- International normalized ratio (INR) ≤ 1.3-fold normal
- Serum albumin ≥ 3.6 gm/dL
- Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile, abstinent, or using 2 proven methods of birth control
- Sexually active male subjects must be practicing acceptable methods of contraception (eg, vasectomy, use of condom plus spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period
- Negative serum ß-human chorionic gonadotropin (HCG, females of child-bearing potential only)
- Provide informed consent
- Willing to comply with all study requirements
Exclusion
- Positive test at Screening for human immunodeficiency virus
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug
- History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the corrected QT (QTc) (Fridericia) interval to \> 450 msec for males or \> 470 msec for females
- Positive results for drugs of abuse at Screening
- Donation or loss of more than 400 mL blood within 2 months prior to anticipated dose administration
- Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration
- Previous exposure to CF102(Cohorts 1 and 2 only)
- Males whose female partner is pregnant
- Serum alpha-feto-protein \> 50 ng/mL at screening
- Any severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00790673
Start Date
July 1 2009
End Date
July 1 2011
Last Update
April 15 2015
Active Locations (1)
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1
Rabin Medical Center
Tel Aviv, Israel