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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: CF 102
Drug: Placebo
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 CF102 1 mg qd Cohort 2 CF102 1 mg Bid Cohort 3 CF102 1 mg Bid Placebo
Hide Arm/Group Description

CF102 1 mg qd

CF 102: Oral capsules

CF102 1 mg bid

CF 102: Oral capsules

CF102 1 mg bid; 16 weeks

CF 102: Oral capsules

Placebo: Matching placebo capsules
Period Title: Overall Study
Started 6 6 12 8
Completed 6 6 12 8
Not Completed 0 0 0 0
Arm/Group Title Cohort 1 CF102 1 mg qd Cohort 2 CF102 1 mg Bid Cohort 3 CF102 1 mg Bid Placebo Total
Hide Arm/Group Description

CF102 1 mg qd

CF 102: Oral capsules

CF102 1 mg bid

CF 102: Oral capsules

CF102 1 mg bid; 16 weeks

CF 102: Oral capsules

Placebo: Matching placebo capsules Total of all reporting groups
Overall Number of Baseline Participants 6 6 12 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants 8 participants 32 participants
45.3  (12.7) 54.5  (8.43) 48.3  (12.4) 42.1  (11.2) 47.3  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants 8 participants 32 participants
Female
3
  50.0%
3
  50.0%
7
  58.3%
3
  37.5%
16
  50.0%
Male
3
  50.0%
3
  50.0%
5
  41.7%
5
  62.5%
16
  50.0%
1.Primary Outcome
Title Adverse Event Profile of Repeated Dosing of CF102
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 CF102 1 mg qd Cohort 2 CF102 1 mg Bid Cohort 3 CF102 1 mg Bid Placebo
Hide Arm/Group Description:

CF102 1 mg qd

CF 102: Oral capsules

CF102 1 mg bid

CF 102: Oral capsules

CF102 1 mg bid; 16 weeks

CF 102: Oral capsules

Placebo: Matching placebo capsules
Overall Number of Participants Analyzed 6 6 12 8
Measure Type: Number
Unit of Measure: participants
6 2 2 4
2.Primary Outcome
Title Effect of Viral Load
Hide Description [Not Specified]
Time Frame 16 weeks
Outcome Measure Data Not Reported
3.Primary Outcome
Title Pharmacokinetic Behavior of CF102 During Repeated Dosing
Hide Description [Not Specified]
Time Frame 16 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects
Hide Description [Not Specified]
Time Frame 16 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 CF102 1 mg qd Cohort 2 CF102 1 mg Bid Cohort 3 CF102 1 mg Bid Placebo
Hide Arm/Group Description

CF102 1 mg qd

CF 102: Oral capsules

CF102 1 mg bid

CF 102: Oral capsules

CF102 1 mg bid; 16 weeks

CF 102: Oral capsules

Placebo: Matching placebo capsules
All-Cause Mortality
Cohort 1 CF102 1 mg qd Cohort 2 CF102 1 mg Bid Cohort 3 CF102 1 mg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Cohort 1 CF102 1 mg qd Cohort 2 CF102 1 mg Bid Cohort 3 CF102 1 mg Bid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/12 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 CF102 1 mg qd Cohort 2 CF102 1 mg Bid Cohort 3 CF102 1 mg Bid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      2/6 (33.33%)      2/12 (16.67%)      4/8 (50.00%)    
Cardiac disorders         
Palpitations [1]  2/6 (33.33%)  6 0/6 (0.00%)  0 0/12 (0.00%)  0 0/8 (0.00%)  0
General disorders         
Fatigue [2]  2/6 (33.33%)  6 0/6 (0.00%)  0 0/12 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders         
HEADACHE [3]  4/6 (66.67%)  6 2/6 (33.33%)  6 2/12 (16.67%)  12 4/8 (50.00%)  8
[1]
Palpitations
[2]
Fatigue
[3]
HEADACHE
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pnina Fishman, PhD
Organization: Can-Fite Biopharma
Phone: 011972 39241114
EMail: pnina@canfite.co.il
Layout table for additonal information
Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00790673    
Other Study ID Numbers: CF102-103HCV
First Submitted: September 17, 2008
First Posted: November 13, 2008
Results First Submitted: March 5, 2015
Results First Posted: April 15, 2015
Last Update Posted: April 15, 2015