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Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C

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ClinicalTrials.gov Identifier: NCT01833845
Recruitment Status : Terminated (due to failure to recruit subjects)
First Posted : April 17, 2013
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
BioLineRx, Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Ribavirin
Drug: Hydroxychloroquine
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ribavirin+HCQ
Hide Arm/Group Description

Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).

Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.

Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Ribavirin+HCQ
Hide Arm/Group Description

Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).

Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.

Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
40 subjects were planned to be included in the study; however, due to the Sponsor's decision, the study was terminated prematurely after 4 subjects had completed the study, due to failure to recruit subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
57.8  (6.0)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 4 participants
4
1.Primary Outcome
Title Efficacy
Hide Description To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.
Time Frame 24 weeks
Outcome Measure Data Not Reported
2.Primary Outcome
Title Safety: Number of Participants With Adverse Events
Hide Description Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms.
Time Frame all 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ribavirin+HCQ
Hide Arm/Group Description:

Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).

Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.

Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
4
3.Secondary Outcome
Title Efficacy
Hide Description To evaluate the efficacy of 8 weeks monotherapy with RBV in HCV-infected patients.
Time Frame 8 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ribavirin+HCQ
Hide Arm/Group Description

Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).

Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.

Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)

All-Cause Mortality
Ribavirin+HCQ
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ribavirin+HCQ
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ribavirin+HCQ
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Eye disorders   
dry eye   1/4 (25.00%)  1
Gastrointestinal disorders   
Upper abdominal pain   1/4 (25.00%)  1
Gastroesophageal reflux disease   1/4 (25.00%)  1
Asthenia   2/4 (50.00%)  2
Nervous system disorders   
Headache   1/4 (25.00%)  1
Dysgeusia   1/4 (25.00%)  1
Psychiatric disorders   
insomnia   2/4 (50.00%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/4 (25.00%)  1
cough   1/4 (25.00%)  1
Vascular disorders   
Hypertension   1/4 (25.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The publication of the results of the Research in their entirety or in part, will be at the sole initiative of BIOLINERX Ltd. Reference to the results of the search cannot be made without the prior written agreement of BioLineRx Ltd..
Results Point of Contact
Name/Title: Dr. Arnon Aharon
Organization: BioLineRx LTD
Phone: 972-2-548-9100 ext 104
Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT01833845     History of Changes
Other Study ID Numbers: BL-8020.01
First Submitted: April 15, 2013
First Posted: April 17, 2013
Results First Submitted: July 30, 2014
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014