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A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1

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ClinicalTrials.gov Identifier: NCT00790673
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : April 15, 2015
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

Tracking Information
First Submitted Date  ICMJE September 17, 2008
First Posted Date  ICMJE November 13, 2008
Results First Submitted Date  ICMJE March 5, 2015
Results First Posted Date  ICMJE April 15, 2015
Last Update Posted Date April 15, 2015
Study Start Date  ICMJE July 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2010)
  • Adverse Event Profile of Repeated Dosing of CF102 [ Time Frame: 16 weeks ]
  • Effect of Viral Load [ Time Frame: 16 weeks ]
  • Pharmacokinetic Behavior of CF102 During Repeated Dosing [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2008)
  • Adverse Event Profile of Repeated Dosing of CF102 [ Time Frame: 2 weeks ]
  • Effect of Viral Load [ Time Frame: 2 weeks ]
  • Pharmacokinetic Behavior of CF102 During Repeated Dosing [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2010)
Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2008)
Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1
Official Title  ICMJE A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety, Tolerability, Biological Activity, and Pharmacokinetics of Orally Administered CF102 in Subjects With Chronic Hepatitis C Genotype 1
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 safety of twice-daily oral dosing with CF102 over a 16-week period; will measure changes in viral load during therapy; and will measure blood concentrations of CF102 at various time points during dosing.
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 in each cohort) to receive qd or bid treatment for 15 days with oral CF-102 or with placebo. Dose escalation will occur in 2 sequential cohorts.

The decision to continue dosing within a cohort (eg, Subcohort 1a to Subcohort 1b), or to escalate to a new dose level Cohort (eg, Subcohort 1b to Subcohort 2a) will be determined by a blinded independent review of safety data. This review will be conducted by a qualified Safety Review Committee comprising the medical monitor, the consulting toxicologist, and an independent expert clinician.

For the first 2 cohorts, subjects will return to the study center for follow-up assessments on Days 8, 15, and 22. Subjects dosed qd will receive a total of 15 doses of CF-102. Subjects dosed bid will receive a total of 29 doses. The 30th dose has been deleted to accommodate PK sampling on the morning of Day 16, 24 hours after the last dose of CF-102.

For the 3rd cohorts, subjects will return to the study center for follow-up assessments on weeks 2, 4, 8, 12, 16 and 18.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: CF 102
    Oral capsules
    Other Name: Cl-IB-MECA
  • Drug: Placebo
    Matching placebo capsules
Study Arms  ICMJE
  • Experimental: 1
    CF102 1 mg qd
    Intervention: Drug: CF 102
  • Experimental: 2
    CF102 1 mg bid
    Intervention: Drug: CF 102
  • Experimental: 3
    CF102 1 mg bid; 16 weeks
    Intervention: Drug: CF 102
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Publications * Bar-Yehuda S, Stemmer SM, Madi L, Castel D, Ochaion A, Cohen S, Barer F, Zabutti A, Perez-Liz G, Del Valle L, Fishman P. The A3 adenosine receptor agonist CF102 induces apoptosis of hepatocellular carcinoma via de-regulation of the Wnt and NF-kappaB signal transduction pathways. Int J Oncol. 2008 Aug;33(2):287-95.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2008)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 to 60 years of age
  2. Body mass index ≤ 30 kg/m2
  3. Either:

    1. 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
    2. a score of F0 or F1 on ActiTest-FibroTest performed within the past year.
  4. Child-Pugh score ≤ 5 at Screening
  5. Serologic evidence of chronic hepatitis C-infection (anti-HCV in serum)
  6. HCV plasma RNA ≥ 1 x 105 IU/mL on 2 separate samples obtained during the screening period.
  7. HCV genotype 1
  8. 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
  9. Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile, abstinent, or using 2 proven methods of birth control
  10. 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
  11. Negative serum ß-human chorionic gonadotropin (HCG, females of child-bearing potential only)
  12. Provide informed consent
  13. Willing to comply with all study requirements

Exclusion Criteria:

  1. Positive test at Screening for human immunodeficiency virus
  2. 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
  3. 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
  4. Positive results for drugs of abuse at Screening
  5. Donation or loss of more than 400 mL blood within 2 months prior to anticipated dose administration
  6. Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration
  7. Previous exposure to CF102(Cohorts 1 and 2 only)
  8. Males whose female partner is pregnant
  9. Serum alpha-feto-protein > 50 ng/mL at screening
  10. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790673
Other Study ID Numbers  ICMJE CF102-103HCV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Can-Fite BioPharma
Study Sponsor  ICMJE Can-Fite BioPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael H Silverman, MD Can-Fite BioPharma Ltd
PRS Account Can-Fite BioPharma
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP