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

NCT00790673 | Completed Phase 1 Results DMC

• 1 other identifier: CF102-103HCV
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C; Viral hepatitis

Outcome Measures

Primary Outcomes (3)

• Adverse Event Profile of Repeated Dosing of CF102

  16 weeks

• Effect of Viral Load

  16 weeks

• Pharmacokinetic Behavior of CF102 During Repeated Dosing

  16 weeks

Secondary Outcomes (1)

• Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects

  16 weeks

Study Arms (4)

1

EXPERIMENTAL

CF102 1 mg qd

Drug: CF 102

2

EXPERIMENTAL

CF102 1 mg bid

Drug: CF 102

3

EXPERIMENTAL

CF102 1 mg bid; 16 weeks

Drug: CF 102

5

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CF 102 DRUG

Oral capsules

Also known as: Cl-IB-MECA

1; 2; 3

Placebo DRUG

Matching placebo capsules

5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (1)

Rabin Medical Center

Tel Aviv, Israel

Location

Related Publications (1)

• 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.

  PMID: 18636149 BACKGROUND

Related Links

• Can-Fite BioPharma

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

2-chloro-N(6)-(3-iodobenzyl)adenosine-5'-N-methyluronamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pnina Fishman, PhD
• Organization: Can-Fite Biopharma

pnina@canfite.co.il

011972 39241114

Study Officials

• Michael H Silverman, MD

  Can-Fite BioPharma Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: September 17, 2008
• First Posted: November 13, 2008
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 15, 2015
• Results First Posted: April 15, 2015

Record last verified: 2012-03

Locations

IL (1)