Chronic Hepatitis CPhase 1/2NCT00790673
A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1
A Phase 1/2 study testing CF 102 in people with Chronic Hepatitis C, run by Can-Fite BioPharma at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- CF 102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Jul 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Being tested
- CF 102, Placebo
- Keywords
- Hepatitis C, Viral hepatitis
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF 102Drug
Also called Cl-IB-MECA
Oral capsules
PlaceboDrug
Matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CF102 1 mg qd Receives: Drug: CF 102 |
| 2 | Experimental | CF102 1 mg bid Receives: Drug: CF 102 |
| 3 | Experimental | CF102 1 mg bid; 16 weeks Receives: Drug: CF 102 |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Profile of Repeated Dosing of CF102
Measured: 16 weeks
Effect of Viral Load
Measured: 16 weeks
Pharmacokinetic Behavior of CF102 During Repeated Dosing
Measured: 16 weeks
Secondary outcomes (1)
Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can-Fite BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H Silverman, MD, Study director, Can-Fite BioPharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790673
- Sponsor's protocol ID
- CF102-103HCV
- Status last verified
- Mar 2012
- First submitted
- 17 Sep 2008
- Last updated
- 15 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 18636149
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00790673
- Acronym / sponsor ID
- CF102-103HCV
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Viral hepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Can-Fite BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 15 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CF 102CF102 1 mg qd |
| 2 | Experimental | Drug: CF 102CF102 1 mg bid |
| 3 | Experimental | Drug: CF 102CF102 1 mg bid; 16 weeks |
| 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 18 to 60 years of age
- Body mass index ≤ 30 kg/m2
- Either:
- Child-Pugh score ≤ 5 at Screening
- Serologic evidence of chronic hepatitis C-infection (anti-HCV in serum)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF 102Also: Cl-IB-MECAOral capsules | Drug | 1, 2, 3 |
| PlaceboMatching placebo capsules | Drug | 5 |
Primary outcome
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
1 secondary outcome
Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18636149Bar-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.
- Can-Fite BioPharmaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Silverman, MD study director
Can-Fite BioPharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CF 102 in people with Chronic Hepatitis C, run by Can-Fite BioPharma at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Profile of Repeated Dosing of CF102 (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00790673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.